Cancer Moonshot Biobank surpasses 1,000 enrollments

The National Cancer Institute’s Cancer Moonshot Biobank^SM recently exceeded its initial goal of 1,000 enrolled participants.

The Biobank collects tissue and blood specimens from patients with advanced cancers who are undergoing standard-of-care treatment at community hospitals across the United States at NCI National Community Oncology Research Program and National Clinical Trials Network sites.

These specimens will enable cancer research aimed at understanding drug sensitivity and resistance—that is, why some patients respond to therapy while others do not, and how tumors evolve under treatment pressure.

“Developing a biobank of blood and tumor tissue collected longitudinally before and during systemic treatment of patients that is clinically annotated has been a major goal of the National Cancer Institute for years,” said James H. Doroshow, M.D., director of the National Cancer Institute Division of Cancer Treatment and Diagnosis. “The achievement of that goal will provide an important new resource for the extramural community that should assist in our understanding of the mechanisms of drug resistance and tumor progression.”

Once the study closes, researchers will be able to request tissue and blood for their studies.

“This initiative will serve the academic community by collection and annotation of clinical data and specimens from patients treated with standard FDA approved treatments—an area that is understudied as most biobank collections deal with patients on clinical trials,” said Lyndsay Harris, M.D., associate director of the Division of Cancer Treatment and Diagnosis and the principal investigator of the Biobank.

Understanding targeted therapies

The Biobank, which enrolled its first participant in 2020, specifically enrolls patients on an FDA-approved (non-experimental) targeted therapy, which is a treatment that targets specific mutations found in the patient’s tumor.

The Frederick National Laboratory for Cancer Research’s Molecular Characterization Laboratory runs a biomarker test on participants’ donated tumor samples. In addition to being used for future research, the resulting biomarker report can help the patient’s physician select the best course of treatment.

Targeted therapies are often more effective and have fewer side effects than other cancer treatments, such as chemotherapy. However, cancer cells can become resistant to a given targeted therapy.

The National Cancer Institute created this collection to serve as a resource for researchers seeking to better understand why this resistance occurs.

“Standardized biospecimens as a part of this biobank will improve research reproducibility and help support precision medicine, biomarker discovery and accelerate translational research,” said Lokesh Agrawal, Ph.D., chief (acting) of the Biorepositories and Biospecimens Research Branch in the Division of Cancer Treatment and Diagnosis.

The longitudinal nature of the Biobank—where it follows patients over the course of their treatment and collects tumor tissue and blood throughout the course of a patient’s cancer treatment—provides a uniquely valuable collection of data and samples to investigate the mechanisms of drug resistance.

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“The Cancer Moonshot Biobank is one of the first national resources to systematically collect longitudinal tumor and blood biospecimens from people receiving standard-of-care targeted therapy or immunotherapy across many cancer types,” said Sean McDermott, Ph.D., scientific project manager in the Molecular Characterization Laboratory. “Rather than collecting a single biopsy at trial enrollment, the Biobank captures tissue and blood at key points in a person’s care—archival, baseline, on-treatment, post-treatment, and at progression—together with rich clinical, radiology, and pathology data.”

Diverse cohort

The Biobank seeks to represent the demographics of the U.S. and thus has partnered with hospitals and cancer centers across the country to run the study.

To date, 1,301 participants have enrolled from 77 community and academic sites in the National Cancer Institute Community Oncology Research Program and National Clinical Trials Network. Of those participants, 17% are Black or African American, 8% are Hispanic or Latino, and 23% live in rural areas. The collection also includes 10 different cancer types.

“Surpassing 1,000 enrolled participants moves the Biobank from a promising concept to a mature national resource,” McDermott said.

To foster a robust cohort, the Biobank launched an extensive engagement effort aimed at both participants and providers. The study team developed a website with a secure portal to provide updates and return biomarker test results directly to participants and their care team.

In addition, the study team works closely with the National Cancer Institute National Community Oncology Research Program and National Clinical Trials Network sites, which handle the consenting, biospecimen collection, and clinical data reporting.

The Biobank also awarded funding through a competitive review process to participating sites interested in launching engagement projects—such as community advisory boards, workshops, and tailored outreach approaches—to support enrollment and retention at their site.

“Enrolling over 1,000 patients to Biobank has been a true team effort that could not have happened without the National Cancer Institute, our colleagues at the Frederick National Laboratory, and the engagement and enthusiasm of our clinical sites,” said Chris Karlovich, Ph.D., Molecular Characterization Laboratory director and co-investigator of the Biobank.

The Biobank will close to enrollment in March 2026 with a follow-up period until March 2027.

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