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2012-07-24
2017-06-01
2017-10-23
133
NCT01658917
National Institutes of Health Clinical Center (CC)
National Institutes of Health Clinical Center (CC)
OBSERVATIONAL
Collecting Solid Tumor Tissue to Identify New Treatments
Background: The NCI Surgery Branch has developed experimental therapies that involve taking white blood cells from patients' tumor or from their blood, growing them in the laboratory in large numbers, and then giving the cells back to the patient. Objective: This study will allow tissue samples obtained during the protocol screening process to be used for future and ongoing research in the NCI Surgery Branch Eligibility: Patients must meet the minimum eligibility criteria for an NCI surgery Branch Treatment Protocol Design Patients will undergo testing and evaluations as required by the appropriate NCI Surgery Branch Treatment protocol
BACKGROUND: * Recent advances and insights into the molecular pathogenesis of cancer have led to the development of novel molecular and biologic targeted therapies for the treatment of advanced cancer patients. A critical challenge in extending these studies involves the identification and validation of new therapeutic targets for future cancer therapies. * The Surgery Branch, NCI has an interest in identifying novel molecular and biologic targets to facilitate the development of future cancer therapies. In addition, we have the primary responsibility for providing surgical consultative services to the NIH. As such, we are uniquely positioned to acquire and perform important studies on solid tumor tissue to help identify therapeutic targets that may have significant clinical ramifications. OBJECTIVES: - Primary Objective: To collect biologic samples from patients undergoing diagnostic or therapeutic interventions for premalignant, primary or metastatic solid tumors for the purpose of identifying novel molecular and biologic therapeutic targets ELIGIBILITY: * Patients >= 18 years of age with radiographic evidence of, biochemical evidence of, or histologically/cytologically proven solid neoplasms who require diagnostic or therapeutic intervention as a part of the diagnosis and /or standard of care treatment and/or follow up for their neoplasm * Patients must have laboratory and physical examination parameters within acceptable limits by standard of practice guidelines prior to planned intervention DESIGN: * A tissue acquisition trial in which tissues will be obtained at the time of intervention * Tissue and blood will be processed at the time of collection, stored and then transferred to Dr. Rosenberg s laboratory for further processing. * No investigational therapy will be given. * It is anticipated that 1000 patients will be enrolled over a period of ten years
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2012-08-03 | N/A | 2023-05-26 |
2012-08-03 | N/A | 2023-05-30 |
2012-08-07 | N/A | 2023-05 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
N/A
Allocation:
N/A
Interventional Model:
N/A
Masking:
N/A
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| : Primary Patients greater than or equal to 18 years of age who have premalignant, primary or metastatic solid tumors based upon either radiographic or biochemical testing, or histological/cytological analysis |
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| To collect biologic samples from patients undergoing diagnostic or therapeutic interventions for premalignant, primary or metastatic solid tumors. | To collect biologic samples from patients undergoing diagnostic or therapeutic interventions for premalignant, primary or metastatic solid tumors for the purpose of identifying novel molecular and biologic therapeutic targets. | At time of surgery or biospy |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| To collect detailed history, demographic, treatment data, and perioperative findings. | To collect detailed history, demographic, treatment data, and perioperative findings in order to categorize and track the specific procedures and outcomes. | At time of consent |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
