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Collecting Solid Tumor Tissue to Identify New Treatments

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ClinicalTrials.gov Identifier: NCT01658917
Recruitment Status : Completed
First Posted : August 7, 2012
Last Update Posted : January 8, 2019
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )

Brief Summary:

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


Condition or disease
Gastrointestinal Cancer Liver Cancer Pancreatic Cancer Melanoma

Detailed Description:

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 greater than or equal to 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. Kammula s laboratory for further processing.
  • No investigational therapy will be given.
  • It is anticipated that 1000 patients will be enrolled over a period of 10 years

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Study Type : Observational
Actual Enrollment : 133 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Prospective Procurement of Solid Tumor Tissue to Identify Novel Therapeutic Targets
Study Start Date : July 19, 2012

Resource links provided by the National Library of Medicine


Group/Cohort
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 :
  1. 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 [ Time Frame: at time of surgery or biospy ]
    To collect biologic samples from patients undergoing diagnostic ortherapeutic interventions for premalignant, primary or metastaticsolid tumors for the purpose of identifying novel molecular andbiologic therapeutic targets


Secondary Outcome Measures :
  1. To collect detailed history, demographic, treatment data, and perioperative findings in order to categorize and track the specific procedures and outcomes. [ Time Frame: at time of consent ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects greater than or equal to 18 years of age from both gender groups and all racial/ethnic groups who are undergoing diagnostic or therapeutic interventions for premalignant, primary or metastatic solid tumors@@@
Criteria
  • INCLUSION CRITERIA:
  • Patients must be greater than or equal to 18 years of age.
  • Patients who have a premalignant, primary or metastatic solid tumors based upon either radiographic or biochemical testing, or histological/cytological analysis that requires surgery or biopsy as a part of the standard of care diagnosis, treatment and/or follow up
  • Patients must have laboratory and physical examination parameters within acceptable limits by standard of practice guidelines prior to biopsy or surgery.
  • Patients must be planning to undergo surgery or biopsy as part of their treatment plan. Note: Patients will not be enrolled exclusively for the procurement of tissue samples.
  • Patients who agree to undergo leukapheresis must meet the following criteria:
  • Seronegative for HIV
  • Seronegative for hepatitis B surface antigen and seronegative for

antibody to hepatitis C.

- CBC within normal limits


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01658917


Locations
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United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Steven A Rosenberg, M.D. National Cancer Institute (NCI)

Additional Information:
Publications:
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Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01658917     History of Changes
Other Study ID Numbers: 120175
12-C-0175
First Posted: August 7, 2012    Key Record Dates
Last Update Posted: January 8, 2019
Last Verified: November 6, 2018

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) ):
Tissue Acquisition

Additional relevant MeSH terms:
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Pancreatic Neoplasms
Liver Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Liver Diseases
Gastrointestinal Diseases