Scientific Review Committee Protocol Submission Form

 
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Pilot can be assigned to any phase.
The definition of a rare cancer is a malignancy that has an annual incidence of <6 per 100,000 cases in the USA.
Total Sample Size

This accrual number is below the mandated minimum accrual for a therapeutic trial.

Individuals are assigned prospectively by an investigator based on a protocol to receive specific interventions. The participants may receive diagnostic, treatment, behavioral, or other types of interventions. The assignment of the intervention may or may not be random. The participants are followed and biomedical and/or health outcomes are assessed.

Studies that focus on cancer patients and healthy populations and involve no prospective intervention or alteration in the status of the participants. Biomedical and/or health outcomes(s) are assessed in pre-defined groups of participants. The participants in the study may receive diagnostic, therapeutic, or other interventions, but the investigator of the observational study is not responsible for assigning specific interventions to the participants of the study.

Studies that are stimulated by, but are not a required part of, a main clinical/study, and that utilize patient or other resources of the main trial/study to generate information relevant to it. Ancillary studies must be linked to an active clinical research study and should include only patients accrued to that clinical research study. Only studies that can be linked to individual patient or participant data should be reported.

Basic Science (BAS): Protocol designed to examine the basic mechanisms of action (e.g., physiology, biomechanics) of an intervention

Diagnostic (DIA): Protocol designed to evaluate one of more interventions aimed at identifying a disease or health conditions.

Health Services Research (HSR): Protocol designed to evaluate the delivery, processes, management, organization, or financing of health care.

Prevention (PRE): Protocol designed to assess one or more interventions aimed at preventing the development of a specific disease or health condition.

Screening (SCR): Protocol designed to assess or examine methods of identifying a condition (or risk factor for a condition) in people who are not known to have the condition (or risk factor).

Supportive Care (SUP): Protocol designed to evaluate one or more interventions where they primary intent is to maximize comfort, minimize side effects, or mitigate against a decline in the participant's health or function. In general, supportive care interventions are not intended to cure a disease.

Treatment (TRE): Protocol designed to evaluate one or more interventions for treating a disease, syndrome, or condition. Note: This equates to therapeutic trials in previous versions of the guidelines.

Other (OTH): Not in other categories.

Files must be less than 100 MB.
Allowed file types: txt pdf doc docx.