National Cancer Institute "Cancer Moonshot Biobank"
Cancer Moonshot Biobank Research Protocol
Sponsor: National Cancer Institute (NCI)
Listed as NCT04314401, this observational or N/A phase trial focuses on Acute Myeloid Leukemia and Anatomic Stage III Breast Cancer AJCC v8 and remains ongoing. Sponsored by National Cancer Institute (NCI), it has been updated 63 times since 2020, reflecting substantial change activity. This study contributes to the evolving evidence base for cancer treatment protocols.
Study Description(click to expand)PRIMARY OBJECTIVE: I. To support current and future investigations into drug resistance and sensitivity and other National Cancer Institute (NCI)-sponsored cancer research initiatives through the procurement and distribution of multiple longitudinal biospecimens and associated data from a diverse group of cancer patients who are undergoing standard of care treatment at NCI Community Oncology Research Program (NCORP) sites and other National Clinical Trials Network (NCTN) sites. SECONDARY OBJECTIVES: I. To provide a service of value to study participants and their medical providers through the performance of molecular profiling assays on tumor samples in a Clinical Laboratory Improvement Act (CLIA)-certified laboratory and reporting of results to physicians and patients that they may opt to use in clinical management, including analysis of data for acquired resistance mechanisms. II. To enable the development of patient-derived models such as cell lines and xenografts for cancer researchers through the provision of biospecimens from up to 20% of study participants to the NCI's Patient Derived Models Repository (PDMR), a national resource available to investigators. III. To develop and implement robust approaches in patient and provider engagement to improve understanding of biobanking and its relationship to cancer research and increase representation of minority and underserved study participants in...
PRIMARY OBJECTIVE:
I. To support current and future investigations into drug resistance and sensitivity and other National Cancer Institute (NCI)-sponsored cancer research initiatives through the procurement and distribution of multiple longitudinal biospecimens and associated data from a diverse group of cancer patients who are undergoing standard of care treatment at NCI Community Oncology Research Program (NCORP) sites and other National Clinical Trials Network (NCTN) sites.
SECONDARY OBJECTIVES:
I. To provide a service of value to study participants and their medical providers through the performance of molecular profiling assays on tumor samples in a Clinical Laboratory Improvement Act (CLIA)-certified laboratory and reporting of results to physicians and patients that they may opt to use in clinical management, including analysis of data for acquired resistance mechanisms.
II. To enable the development of patient-derived models such as cell lines and xenografts for cancer researchers through the provision of biospecimens from up to 20% of study participants to the NCI's Patient Derived Models Repository (PDMR), a national resource available to investigators.
III. To develop and implement robust approaches in patient and provider engagement to improve understanding of biobanking and its relationship to cancer research and increase representation of minority and underserved study participants in cancer research.
IV. To develop increased capabilities in United States (U.S.) community hospitals and clinics for contribution to cancer research through biobanking activities.
V. To enable secondary research generated from the project through deposition of data in public repositories such as Cancer Research Data Commons (CRDC), The Cancer Imaging Archive (TCIA) and database of Genotypes and Phenotypes (dbGaP) and other potential NCI databases, including clinical, radiology and pathology data with an emphasis on treatment response and outcome data.
VI. To provide residual biospecimens and associated data from the project to the cancer research community.
OUTLINE:
Patients undergo collection of tissue samples during baseline and at time of disease progression and collection of blood samples throughout the study, including at time of disease progression. Patients with hematological malignancies also undergo collection of bone marrow and cerebral spinal fluid at the same time points. Archival blood and tissue, as well as bone marrow of patients with hematological malignancies, is also collected if available. Additionally, patients may undergo computed tomography (CT), positron emission tomography (PET)/CT and/or magnetic resonance imaging (MRI) throughout the study, and may undergo paracentesis on study. Patient medical records are reviewed, and data is collected for at least 5 years.
Status Flow
Change History
63 versions recorded-
May 4, 2026 — Present [daily]
Active Not Recruiting
Status: Recruiting → Active Not Recruiting
-
Mar 2026 — May 2026 [monthly]
Recruiting
-
Feb 2026 — Mar 2026 [monthly]
Recruiting
-
Jan 2026 — Feb 2026 [monthly]
Recruiting
-
Dec 2025 — Jan 2026 [monthly]
Recruiting
▶ Show 58 earlier versions
-
Nov 2025 — Dec 2025 [monthly]
Recruiting
-
Oct 2025 — Nov 2025 [monthly]
Recruiting
-
Sep 2025 — Oct 2025 [monthly]
Recruiting
-
Aug 2025 — Sep 2025 [monthly]
Recruiting
-
Jul 2025 — Aug 2025 [monthly]
Recruiting
-
Jun 2025 — Jul 2025 [monthly]
Recruiting
-
May 2025 — Jun 2025 [monthly]
Recruiting
-
Apr 2025 — May 2025 [monthly]
Recruiting
-
Mar 2025 — Apr 2025 [monthly]
Recruiting
-
Feb 2025 — Mar 2025 [monthly]
Recruiting
-
Jan 2025 — Feb 2025 [monthly]
Recruiting
-
Dec 2024 — Jan 2025 [monthly]
Recruiting
-
Nov 2024 — Dec 2024 [monthly]
Recruiting
-
Oct 2024 — Nov 2024 [monthly]
Recruiting
-
Sep 2024 — Oct 2024 [monthly]
Recruiting
-
Aug 2024 — Sep 2024 [monthly]
Recruiting
-
Jul 2024 — Aug 2024 [monthly]
Recruiting
-
Jun 2024 — Jul 2024 [monthly]
Recruiting
-
May 2024 — Jun 2024 [monthly]
Recruiting
-
Apr 2024 — May 2024 [monthly]
Recruiting
-
Mar 2024 — Apr 2024 [monthly]
Recruiting
-
Feb 2024 — Mar 2024 [monthly]
Recruiting
-
Jan 2024 — Feb 2024 [monthly]
Recruiting
-
Dec 2023 — Jan 2024 [monthly]
Recruiting
-
Nov 2023 — Dec 2023 [monthly]
Recruiting
-
Oct 2023 — Nov 2023 [monthly]
Recruiting
-
Sep 2023 — Oct 2023 [monthly]
Recruiting
-
Aug 2023 — Sep 2023 [monthly]
Recruiting
-
Jul 2023 — Aug 2023 [monthly]
Recruiting
-
Jun 2023 — Jul 2023 [monthly]
Recruiting
-
May 2023 — Jun 2023 [monthly]
Recruiting
-
Apr 2023 — May 2023 [monthly]
Recruiting
-
Dec 2022 — Apr 2023 [monthly]
Recruiting
-
Nov 2022 — Dec 2022 [monthly]
Recruiting
-
Sep 2022 — Nov 2022 [monthly]
Recruiting
-
Jul 2022 — Sep 2022 [monthly]
Recruiting
-
May 2022 — Jul 2022 [monthly]
Recruiting
-
Apr 2022 — May 2022 [monthly]
Recruiting
-
Mar 2022 — Apr 2022 [monthly]
Recruiting
-
Feb 2022 — Mar 2022 [monthly]
Recruiting
-
Jan 2022 — Feb 2022 [monthly]
Recruiting
-
Dec 2021 — Jan 2022 [monthly]
Recruiting
-
Nov 2021 — Dec 2021 [monthly]
Recruiting
-
Oct 2021 — Nov 2021 [monthly]
Recruiting
-
Sep 2021 — Oct 2021 [monthly]
Recruiting
-
Jun 2021 — Sep 2021 [monthly]
Recruiting
-
May 2021 — Jun 2021 [monthly]
Recruiting
-
Apr 2021 — May 2021 [monthly]
Recruiting
-
Mar 2021 — Apr 2021 [monthly]
Recruiting
-
Feb 2021 — Mar 2021 [monthly]
Recruiting
-
Jan 2021 — Feb 2021 [monthly]
Recruiting
-
Dec 2020 — Jan 2021 [monthly]
Recruiting
-
Nov 2020 — Dec 2020 [monthly]
Recruiting
-
Oct 2020 — Nov 2020 [monthly]
Recruiting
Status: Not Yet Recruiting → Recruiting
-
Jul 2020 — Oct 2020 [monthly]
Not Yet Recruiting
-
Jun 2020 — Jul 2020 [monthly]
Not Yet Recruiting
-
May 2020 — Jun 2020 [monthly]
Not Yet Recruiting
-
Apr 2020 — May 2020 [monthly]
Not Yet Recruiting
First recorded
Eligibility Summary
This trial collects multiple tissue and blood samples, along with medical information, from cancer patients. The "Cancer Moonshot Biobank" is a longitudinal study. This means it collects and stores samples and information over time, throughout the course of a patient's cancer treatment. By looking at samples and information collected from the same people over time, researchers hope to better understand how cancer changes over time and over the course of medical treatments.
Contact Information
- National Cancer Institute (NCI)
For direct contact, visit the study record on ClinicalTrials.gov .