Clinical trial NCT05600933: Prospective Procurement of Tumor Tissue to Identify Novel Therapeutic Targets and Study the Tumor Microenvironment
Official title: Prospective Procurement of Tumor Tissue to Identify Novel Therapeutic Targets and Study the Tumor Microenvironment
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Solid Tumors
Hematologic Malignancy
Gastrointestinal Cancer
Liver Cancer
Pancreatic Cancer
Melanoma
Pre-Malignancy
Lung Cancer
Keywords: Biologic Samples
Intratumoral Immunologic Landscape
Tumor Infiltrating Lymphocytes
Immuno-Oncology Therapeutics
Natural History
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2022-11-01
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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

Brief summary: 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.

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.

Eligibility criteria: * 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.

Primary outcomes:
measure: To collect biologic samples from participants undergoing diagnostic or therapeutic interventions for premalignant, primary or metastatic solid tumors and hematologic malignancies
timeFrame: At time of surgery or biopsy
Secondary outcomes:
measure: To collect detailed history, demographic, treatment data, and perioperative findings.
timeFrame: At time of consent
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Institutes of Health Clinical Center
state: Maryland
Study officials:
affiliation: National Cancer Institute (NCI)
name: Steven A Rosenberg, M.D.
role: PRINCIPAL_INVESTIGATOR
References: