Prospective Procurement of Tumor Tissue to Identify Novel Therapeutic Targets and Study the Tumor Microenvironment

Background:

Many advances have been made in cancer treatments, but more research is needed. Comparing samples of cancerous tissue to samples of normal, noncancerous tissues may help find differences between them. These differences may help researchers find new ways to treat cancer.

Objective:

To collect tissues and blood samples from people with known or suspected cancer. The samples will be used to help identify new targets for cancer treatments.

Eligibility:

People aged 18 years and older with a known or suspected cancer that requires surgery or biopsy.

Design:

Participants will be screened. They will answer questions about their health. They can do this on the phone or in person.

Researchers will collect information from participants medical records. Data may include information about any prior or current cancers. Data about other medical conditions may also be collected.

Participants will have blood drawn. Some of the blood will be tested for HIV and hepatitis B and C. Some of the blood will be used for genetic research.

Participants will have tissue samples collected during surgeries or biopsies. These are procedures the participants would have had as part of their standard care. No new procedures will be done just for this study. Researchers may also seek out samples from prior procedures the participant had done.

Participants will remain in the study for 6 months. They may have blood drawn again. Researchers may also collect tissue samples from any procedures performed during that time.

Study Overview

• Status: Enrolling by invitation
• Conditions: Melanoma; Pancreatic Cancer; Lung Cancer; Solid Tumors; Gastrointestinal Cancer; Hematologic Malignancy; Liver Cancer; Pre-Malignancy

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 participants. A critical challenge in extending these studies involves the identification and validation of new therapeutic targets for future cancer therapies.
• The development of immuno-oncology therapeutics across a wide spectrum of malignancies has emphasized a need to understand the intratumoral immunologic landscape of metastatic cancer. The techniques of cultivating and examining tumor infiltrating lymphocytes developed in the Surgery Branch can be expanded and refined by the exploration of solid tumors.
• The Surgery Branch, NCI has an interest in identifying novel molecular and biologic targets to facilitate the development of future cancer therapies for solid and hematologic malignancies. Through close collaborations with the Surgical Oncology Program and Thoracic Surgery Branch, our internal staff surgeons, and our medical oncology staff clinicians, we are uniquely positioned to acquire and perform important studies on solid tumor tissue and bone marrow to help identify therapeutic targets that may have significant clinical ramifications.

Objective:

To collect biologic samples from participants undergoing diagnostic or therapeutic interventions for known or suspected cancer for the purpose of identifying novel molecular and biologic therapeutic targets and studying the intratumoral immune landscape.

Eligibility:

Participants >=18 years of age with suspected or confirmed malignancies planning diagnostic or therapeutic intervention from which biologic samples may be obtained.

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 the Surgery Branch Cell Production Facility for further processing.
• No investigational therapy will be given.
• It is anticipated that 1200 participants will be enrolled.

• Study Type: Observational
• Enrollment (Estimated): 1200

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 or hematologic malignancies

Description

• INCLUSION CRITERIA:
• Age >= 18 years
• Willing to undergo serologic testing for HIV, hepatitis B and C
• Participants who have a known or suspected cancer that requires surgery or biopsy as a part of the standard of care diagnosis, treatment and/or follow up.

Note: Participants will not be enrolled exclusively for the procurement of tissue samples.

-Able and willing to sign an informed consent document.

Study Plan

How is the study designed?

Design Details

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

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
1 - premalignant, primary or metastatic solid tumor; Participants >= 18 with a suspected or confirmed solid tumor malignancy that requires surgery or biopsy.
2 - known or suspected hematologic malignancy; Participants >= 18 who have a known or suspected hematologic malignancy that requires surgery or biopsy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To collect biologic samples from participants undergoing diagnostic or therapeutic interventions for premalignant, primary or metastatic solid tumors and hematologic malignancies	To collect biologic samples from participants undergoing diagnostic or therapeutic interventions for known or suspected cancer for the purpose of identifying novel molecular and biologic therapeutic targets and studying the intratumoral immune landscape.	At time of surgery or biopsy

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 specimens.	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

Helpful Links

• NIH Clinical Center Detailed Web Page

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2023
• Primary Completion (Estimated): June 15, 2033
• Study Completion (Estimated): June 15, 2033

Study Registration Dates

• First Submitted: October 25, 2022
• First Submitted That Met QC Criteria: October 31, 2022
• First Posted (Actual): November 1, 2022

Study Record Updates

• Last Update Posted (Estimated): December 5, 2023
• Last Update Submitted That Met QC Criteria: December 2, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Natural History; Biologic Samples; Intratumoral Immunologic Landscape; Tumor Infiltrating Lymphocytes; Immuno-Oncology Therapeutics
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Site; Hematologic Diseases; Digestive System Neoplasms; Gastrointestinal Diseases; Neoplasms; Hematologic Neoplasms; Gastrointestinal Neoplasms
• Other Study ID Numbers: 10000958; 000958-C

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.@@@@@@In addition, all large scale genomic sequencing data will be shared with subscribers to dbGaP
• IPD Sharing Time Frame: Clinical data will be available during the study and indefinitely.@@@@@@Genomic data will be available once genomic data are uploaded per protocol GDS plan for as long as database is active.
• IPD Sharing Access Criteria: Clinical data will be made available via subscription to BTRIS and with the permission of the study PI.@@@@@@Genomic data will be made available via dbGaP through requests to the data custodians.
• 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
• product manufactured in and exported from the U.S.: No