Guidelines for the preparation of E.R.T.C. cancer clinical trial protocols.
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Clinical Trials as Topic↗
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Explore indexed PubMed citations for clinical trials, systematic reviews and public health research. Read source abstracts and follow each citation to its original PubMed record.
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Involving communities in the design of clinical trial protocols: the BAN Study in Lilongwe, Malawi.
OBJECTIVE: To learn the attitudes and concerns of the local community on participating in research, infant feeding practices, and maternal nutrition in order to inform the design of a clinical trial in Lilongwe, Malawi on the safety and efficacy of antiretroviral and nutrition interventions to reduce postnatal transmission of HIV. DESIGN: Formative research methods were used, including semi-structured interviews, focus group discussions, home observations, and taste trials. Data were collected, analyzed, and incorporated into the protocol within 3 months. RESULTS: Participants were supportive of the clinical trial, although their overall understanding of research was limited. Mothers agreed that infants' blood could be drawn by venipuncture, yet concern was raised about the amount of blood proposed to be collected from both infants and mothers. Data demonstrated that rapid breastfeeding cessation would be difficult and malnutrition could be a risk if infants were weaned early. Mothers selected a maternal supplement suitable for use in the clinical trial. CONCLUSIONS: The protocol was rapidly modified to achieve cultural acceptability while maintaining study objectives. Without the formative research, several significant areas would have been undetected and may have jeopardized the implementation of the trial. Additional research was carried out to develop a meaningful informed consent process, the amount of blood collected was reduced to acceptable levels, and the protocol was modified to reduce the risk of malnutrition. Researchers who conduct clinical trials are encouraged to incorporate formative research into their protocol design to ensure participant understanding of the research, to safeguard participants, and to increase feasibility and acceptance of the clinical research in the community.
Adult↗
Granulocyte colony stimulating factor (G-CSF) for mustard-induced bone marrow suppression.
The authors describe the development of a clinical protocol to treat mustard gas-induced myelosuppression with granulocyte colony stimulating factor (G-CSF), a hematopoietic growth factor. Limited clinical evidence suggests a significant role for mustard gas-induced myelosuppression in the overall morbidity of mustard gas victims. Initial data from primates revealed that G-CSF could ameliorate neutropenia following nitrogen mustard exposure. Exploiting the extensive oncologic experience with G-CSF, which demonstrated its safety and absence of serious side effects the authors developed a clinical protocol for use of this drug in potential mustard gas victims in the Persian Gulf conflict.
Animals↗
Development of a 500-Hz masking-level difference protocol for clinic use.
The purpose of this series of experiments was to develop a simple, 500-Hz masking-level difference (MLD) protocol that could be implemented easily in the clinic to assess auditory perceptual abilities using an audio compact disc. Five, 300-ms tones with 250-ms intertone intervals were embedded in 3-s bursts of 200-800 Hz noise presented at 42.2-dB pressure-spectrum level with 4-5 s interstimulus intervals. The homophasic and antiphasic conditions were interleaved with the signal-to-noise ratios decreasing in 2-dB steps. A single-interval, "yes/no" response task was used. Three experiments were performed on 24-28 listeners with normal hearing. The mean SoNo thresholds (58.1- to 59.5-dB SPL) and the mean SpiNo thresholds (45.1- to 46.0-dB SPL) produced approximately 13-dB MLDs. Experiment 3 included a SoNpi condition that had a mean threshold of 48.8-dB SPL and a 10.0-dB MLD. The mean test, retest of the SoNo and SpiNo thresholds on 15 listeners was < 0.5 dB. Over the three experiments, 95% of the listeners had SpiNo MLDs that were > or = 10 dB.
Acoustic Stimulation↗
Five year follow-up of a smoking withdrawal clinic population.
Eight hundred volunteers who attended smoking clinics at Roswell Park Memorial Institute from 1964-1965 were followed up five years later to ascertain their current smoking status. From three waves of a mailed questionnaire, plus a telephone campaign, we obtained 559 usable responses. The relationship between smoking status at the five-year follow-up and clinic protocols and selected social and psychological characteristics as determined during the clinics were examined. Of those individuals contacted five years after the clinic, 17.8 per cent were not smoking. Variations in clinic protocol in terms of drugs and education methods had no relation to long-term smoking withdrawal. Several social and psychological variables, however, were related to smoking behavior five years after the clinics. Non-smokers were more likely than smokers to be males, to be older, to have smoked less before the clinic, to have started smoking at a later age, to have a milieu that was supportive of their stopping, and to have fewer indices of neurosis and fewer psychosomatic symptoms.
Adolescent↗
[Accidental punctures: ten years of experience with our protocol].
OBJECTIVE: We report our experience during the past 10 years in the management of accidental punctures. PATIENTS AND METHODS: A study was made of all hypodermic needle punctures recorded in children aged 0-14 years in our center since 1987. A clinical protocol consisting of 5 visits and duration of 6-7 months was used in all cases. RESULTS: A total of 150 punctures were recorded during the study period with a decrease in prevalence over time. All cases the clinical protocol was accepted and correct follow-up procedures were performed. In no case was post-puncture sero-conversion detected for HCV, HBV, or HIV among correctly immunized children. CONCLUSIONS: The protocol employed is useful and well accepted with the risk of infection caused by accidental puncture being remote provided initial patient care was adequate.
Accidents↗
Planning restorative treatment for patients with severe Class II malocclusions.
This article describes a clinical protocol for the occlusal rehabilitation of patients with severe Angle skeletal Class II malocclusions. Within this protocol, an occlusal device is used for 2 purposes: first, to locate the most suitable maxillary-mandibular relationship for function and range of motion at an established vertical dimension of occlusion; and second, to accurately transfer this relationship to an articulator for fabrication of provisional and definitive restorations. The theory behind this protocol and its associated clinical procedures is presented along with a discussion of the protocol's advantages and disadvantages.
Centric Relation↗
Conflict of interest in biomedical research: a view from Europe.
In this paper I address the conflict of interest (CoI) issue from a legal point of view at a European level. We will see that the regulatory framework that exists in Europe does state the need for the independence of ethics committee involved in authorisation of research and clinical trials. We will see that CoI is an element that has to be closely monitored at National and International level. Therefore, Member States and Newly Associated States do have to address CoI in the authorisation process of research and clinical protocols of biomedicine.
Biomedical Research↗
Preliminary report on the use of high-fidelity simulation in the training of study coordinators conducting a clinical research protocol.
Training of health care research personnel is a critical component of quality assurance in clinical trials. Interactivity (such as simulation) is desirable compared with traditional methods of teaching. We hypothesized that the addition of an interactive simulation exercise to standard training methods would increase the confidence of study coordinators. A simulation exercise was developed to replicate a complex clinical trial. Eighteen study coordinators completed pre- and postexercise confidence questionnaires. Questions were targeted at key trial components using a 0-10 scale (not confident to confident) and were categorized using Bloom's Taxonomy. The primary analysis compared overall mean pre- and postexercise responses. Secondary analyses assessed affective, psychomotor, and cognitive confidence. Significance was at P < 0.05. A significant increase in overall confidence (8.64 versus 5.77; P < 0.0001) was reproduced in the subcategory analyses (affective, 8.24 versus 4.89; P < 0.0001; cognitive, 8.75 versus 6.42; P = 0.0003; psychomotor, 8.63 versus 5.26; P < 0.0001). A high level of internal consistency and reliability in question responses within domains was observed, validating the questionnaire tool. In this preliminary report, we confirmed that addition of a simulation exercise to the training of study coordinators resulted in increased confidence. Simulation exercises should be considered when training study coordinators for clinical research trials.
Adult↗
Facial thermography, basis, protocol, and clinical value.
Computerized electronic telethermography provides clinicians with a reliable evaluation of subtle body surface temperature changes that show underlying physical disorders characterized by pain. The first study population involved 4000 measurements of 100 volunteers at the Medical School of New Jersey. This study of normal volunteers evaluates the validity and reliability of using 0.5 degrees C skin surface temperature difference between opposite sides of the head as a minimum difference standard for recognition of a clinically significant thermographic abnormality. A second study population of over 300 patients with clinically suspected temporomandibular disorder were used. The authors used a standard thermographic protocol procedure that is approved by the Academy of Neuromuscular Thermography. Also discussed in detail are artifactual influences and trigger point detection. The clinical value of this information in the diagnosis and treatment of temporomandibular disorder patients is self evident.
Adult↗
Ten questions institutional review boards should ask when reviewing international clinical research protocols.
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Clinical Trials as Topic↗
Initial experience combining cyclooxygenase-2 inhibition with chemoradiation for locally advanced pancreatic cancer.
Pancreatic cancer is a lethal disease that is resistant to chemotherapy and radiotherapy. Gemcitabine has recently been shown to be an improvement over 5-fluorouracil in patients with advanced disease. It is also a potent radiosensitizer, which has led to the investigation of gemcitabine with concurrent radiotherapy. However, preliminary results indicate that there are significant limitations to this approach in this challenging disease. Pancreatic cancer cells have alterations in many molecular signaling pathways that may be responsible for their resistance to cytotoxic therapy and aggressive behavior. Cyclooxygenase-2 (COX-2) is commonly overexpressed in pancreatic tumors, and preclinical evidence indicates that selective COX-2 inhibition enhances both chemotherapy and radiotherapy response, without affecting normal tissue damage. We have initiated preclinical studies as well as a phase I clinical protocol evaluating the combination of gemcitabine and celecoxib (Celebrex) with radiotherapy. In preclinical studies, celecelecoxib strongly enhanced the antitumor efficacy of chemoradiation. However, preliminary observations from both the preclinical experiments as well as the clinical protocol have revealed more toxicity with this combination than with gemcitabine and radiotherapy alone. These observations require further study, but are cause for concern when combining gemcitabine, radiotherapy, and celecoxib.
Adenocarcinoma↗
Conceptual frameworks for clinical practice.
The patient with neurologic dysfunction is confronted with an enormous challenge. First, he/she is faced with the physiologic and psychological changes associated with the condition. Secondly, this individual may require hospitalization, which demands adaptations in his/her self-concept and family roles and responsibilities. Thirdly, treatment of the dysfunction may necessitate long-term medical management which would challenge his/her self-care abilities and the functioning of the family system. The concepts of body image, self-concept, self-care, and family systems have been synthesized into a conceptual framework relevant to patient populations experiencing neurologic/neurosurgical problems. This conceptual framework provides a structure which can be utilized to explain the reactions and behavior of patients, formulate generalizations relevant to this population, and develop and test clinical protocols. Individual nurses interacting with neurological/neurosurgical patients need to utilize this conceptual framework to develop and test clinical protocols that are pertinent to their own unique clinical situation. Communication of the results of this process will foster the expansion of the scientific knowledge base for clinical practice.
Humans↗
[Gene therapy].
Recent progress of gene manipulation techniques enables us to insert foreign gene into human cells. This approach, so called gene therapy, is very attractive to treat molecular disease including congenital disorders or cancer. There have already been started 15 clinical protocols regarding gene therapy as well as gene-marking mainly in U.S.A., In this reviewing article, we introduce the public opinion about the gene therapy in Japan comparing with that in western countries. We then introduce the current clinical protocols about gene therapy and gene marking. We also discuss the future prospects of gene therapy. The progress in this field may cast a new light on the treatment of congenital disorders as well as cancers.
Attitude to Health↗
Electronic clinical trial protocol distribution via the World-Wide Web: a prototype for reducing costs and errors, improving accrual, and saving trees.
Clinical trials today typically are inefficient, paper-based operations. Poor community physician awareness of available trials and difficult referral mechanisms also contribute to poor accrual. The Physicians Research Network (PRN) web was developed for more efficient trial protocol distribution and eligibility inquiries. The Medical University of South Carolina's Hollings Cancer Center trials program and two community oncology practices served as a testbed. In 581 man-hours over 18 months, 147 protocols were loaded into PRN. The trials program eliminated all protocol hardcopies except the masters, reduced photocopier use 59%, and saved 1.0 full-time equivalents (FTE), but 1.0 FTE was needed to manage PRN. There were no known security breaches, downtime, or content-related problems. Therefore, PRN is a paperless, user-preferred, reliable, secure method for distributing protocols and reducing distribution errors and delays because only a single copy of each protocol is maintained. Furthermore, PRN is being extended to serve other aspects of trial operations.
Clinical Trials as Topic↗
[Clinical and diagnostic imaging of labrum lesions in the hip joint].
Labral lesions are common findings in residual hip dysplasia, indicating biomechanical decompensation of the hip joint. MR-Arthrography has shown an excellent accuracy of over 90% to detect these lesions. Nevertheless, so far clinical sings, radiological diagnosis and therapeutical consequences are not well known. In a prospective study, patients suspicious for labral lesions were evaluated using a standard clinical protocol, including history, clinical signs, radiography and MR-Arthrography. Clinical signs were tested by six criteria and two provocation tests. In 11% patients clinical suspicious was wrong. Best agreement with MR-Arthrography was found for "knife sharp" groin pain (100%), impingement test (100%) and painful giving way (83%). 35% of patients showed minor (grade 2) and 52% severe (grade 3 and 4) dysplasia. Independent from grade of dysplasia, no or only slight arthrosis (grade 0 and 1) was found in 64% of patients. In 16% a single acetabular cyst could be detected on radiographs, which all could be identified as intraosseous ganglia on MR-Arthrography. Labral lesions type A (post traumatic) were found in 23% of the patients with only no or minor dysplasis (grade 1 and 2), whereas labral lesions type B (dysplastic) were found in 67% of the patients with severe dysplasia (grade 3 and 4). Clinical signs for labral lesions are typical but can also be observed in other pathologies of the hip joint. Based on the findings of this study, we recommend radiographic evaluation for dysplasia and MR-Arthrography in patients with clinical suspicion for labral lesions of the hip joint.
Acetabulum↗
Comparison of fluorine-18 and bromine-76 imaging in positron emission tomography.
State of the art positron emission tomography (PET) systems allow for scatter and attenuation correction. However, the size of the structure being studied and the region of interest (ROI) chosen also influence the accuracy of measurements of radioactive concentration. Furthermore, the limited spatial resolution of PET tomographs, which depends, among other factors, on the range of positrons in matter, can also contribute to a loss in quantitation accuracy. In this paper we address the influence of positron range, structure size and ROI size on the quantitation of radioactive concentration using PET. ECAT EXACT HR+ (HR+) and ECAT 953B/31 (ECAT 953B) PET systems were used in phantom acquisitions performed with two radioisotopes with different positron ranges. The 3D Hoffman phantom was scanned on both scanners with both radioisotopes, to visually analyse the image quality. A resolution phantom having six spheres of different diameters in a Plexiglas cylinder was used to calculate the values of the contrast recovery coefficient or hot spot recovery coefficient and of the spill-over or cold spot recovery coefficient under different imaging conditions used in clinical routine at our institution. Activity ratios were varied between 2 and 30 or between 0.4 and 200 by filling the spheres with fluorine-18 or bromine-76 respectively and the cylinder with 11C. Dynamic scans were performed on each scanner. Data were reconstructed using the same parameters as are used in clinical protocols. The variations in sphere and cylinder activities with time were fitted using the function M(t)=k1. A(t)+k2.B(t), where M(t) is the radioactivity concentration measured in an ROI placed on each sphere and A(t) and B(t) represent the true radioactivity concentrations present at time t in the spheres and in the cylinder respectively. k1 and k2 are factors representing the contrast recovery coefficient and the spill-over from surrounding activity on measurements respectively. The visual analysis of images obtained using a 3D Hoffman phantom showed that image resolution and image contrast between different regions are radioisotope dependent and clearly better when using 18F. Linear profiles taken on these images confirmed the visual assessment. For a given scanner, the k1 values obtained with 18F were systematically higher than those measured using 76Br in the same machine (especially for the smaller spheres) when using the same ROI. For a sphere of a particular diameter, the use of a wider ROI resulted in lower quantitative accuracy when using the same isotope and the same camera. Lower quantitative accuracy was found for smaller spheres for all ROI sizes used in image analysis. For the same scanner and for a similar imaging situation (same sphere and same ROI), it was found that k1 and k2 values depend on the radioisotope used. For the same isotope and tomograph, the k1 values obtained decreased with the size of the structures imaged, as well as with the increase in ROI size. The use of a tomograph with better spatial resolution (HR+, rather than ECAT 953B) greatly increased the k1 values for 18F while only a mild improvement in these values was observed for 76Br. The use of 76Br led to k2 values that were slightly higher than those measured using 18F. These differences may have been due to the difference in the range of the positrons emitted by the radioisotopes used in this study. The measurements performed in this study show that the comparison of studies obtained on the same camera depends on the radioisotope used and may require the adaptation of ROI size between examinations. Marked differences are visible if the positron ranges of such radioisotopes are very different. Therefore, when employing commercially available tomographs and imaging protocols used in clinical routine, the effects of differences in positron range on image quality and quantitation are noticeable and correction for these effects may be of importance. (ABSTRACT TRUNCATED)
Brain↗
Targeting growth factors and angiogenesis; using small molecules in malignancy.
Targeted biologic therapy for cancer has evolved from the laboratory to active clinical protocols and applied clinical practice in selected patients. Major targets include epidermal growth factor, and vascular endothelial growth factor receptors which are commonly expressed in gastro-intestinal cancers head & neck and lung cancers, and to some degree breast and gynecologic malignancy. Down stream signal transduction pathway inhibition of B-raf and N-ras mutations are examined in melanoma. New approaches involving re-packaging of chemotherapeutic agents are being exemplified in the nanoparticle formulation of paclitaxel which provides increased access to endothelial and tumor cells with potential enhanced therapeutic efficacy compared to the conventional version solubilized in a cremophor.
Angiogenesis Inhibitors↗