Collecting Solid Tumor Tissue to Identify New Treatments

Prospective Procurement of Solid Tumor Tissue to Identify Novel Therapeutic Targets

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

Study Overview

• Status: Completed
• Conditions: Melanoma; Pancreatic Cancer; Gastrointestinal Cancer; Liver Cancer

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 >= 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

• Study Type: Observational
• Enrollment (Actual): 133

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Bethesda, Maryland, United States, 20892
      • National Institutes of Health Clinical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• 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@@@

Description

• 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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Outcome Measure	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

Collaborators and Investigators

• Sponsor: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Steven A Rosenberg, M.D., National Cancer Institute (NCI)

Publications and helpful links

General Publications

• Longo DL. Tumor heterogeneity and personalized medicine. N Engl J Med. 2012 Mar 8;366(10):956-7. doi: 10.1056/NEJMe1200656. No abstract available.
• Yachida S, Jones S, Bozic I, Antal T, Leary R, Fu B, Kamiyama M, Hruban RH, Eshleman JR, Nowak MA, Velculescu VE, Kinzler KW, Vogelstein B, Iacobuzio-Donahue CA. Distant metastasis occurs late during the genetic evolution of pancreatic cancer. Nature. 2010 Oct 28;467(7319):1114-7. doi: 10.1038/nature09515.
• Gerlinger M, Rowan AJ, Horswell S, Math M, Larkin J, Endesfelder D, Gronroos E, Martinez P, Matthews N, Stewart A, Tarpey P, Varela I, Phillimore B, Begum S, McDonald NQ, Butler A, Jones D, Raine K, Latimer C, Santos CR, Nohadani M, Eklund AC, Spencer-Dene B, Clark G, Pickering L, Stamp G, Gore M, Szallasi Z, Downward J, Futreal PA, Swanton C. Intratumor heterogeneity and branched evolution revealed by multiregion sequencing. N Engl J Med. 2012 Mar 8;366(10):883-892. doi: 10.1056/NEJMoa1113205. Erratum In: N Engl J Med. 2012 Sep 6;367(10):976.

Helpful Links

• NIH Clinical Center Detailed Web Page

Study record dates

Study Major Dates

• Study Start (Actual): July 24, 2012
• Primary Completion (Actual): June 1, 2017
• Study Completion (Actual): October 23, 2017

Study Registration Dates

• First Submitted: August 3, 2012
• First Submitted That Met QC Criteria: August 3, 2012
• First Posted (Estimated): August 7, 2012

Study Record Updates

• Last Update Posted (Actual): May 30, 2023
• Last Update Submitted That Met QC Criteria: May 26, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Natural History; Tissue Acquisition
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Digestive System Neoplasms; Gastrointestinal Diseases; Gastrointestinal Neoplasms
• Other Study ID Numbers: 120175; 12-C-0175

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: .All IPD recorded in the medical record will be shared with intramural investigators upon request.
• IPD Sharing Time Frame: Clinical data will be available during the study and indefinitely.
• IPD Sharing Access Criteria: Clinical data will be made available via subscription to BTRIS and with the permission of the study PI.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No