The Alliance for Clinical Trials in Oncology, in partnership with the National Cancer Institute, part of the National Institutes of Health, today announced the opening of a new study for participant enrollment that aims to obtain a reference set of blood samples from newly diagnosed patients with cancer and healthy individuals without cancer to include in a future study to assess the utility of early cancer detection blood tests.
The Alliance Multicancer Early Detection (MCED) Biobank Study plans to enroll about 2,000 people. Participants will have a blood sample collected and will complete a health questionnaire. Participants with cancer will have an option to provide a tissue sample. All participants will be asked to provide another blood sample after one year.
"The Alliance MCED reference set and the validation of multi-cancer screening assays will create an opportunity for MCED testing to reduce cancer mortality and treatment costs for patients, improve the effectiveness of cancer screening, and complement single-cancer screening approaches, said Electra D. Paskett, PhD, Director of the Alliance Cancer Control Program and Principal Investigator for the Alliance NCI Community Research Oncology Program (NCORP) Research Base.
Despite many advances, cancer remains the second leading cause of death worldwide. Today, there is no screening available for most life-threatening cancers, and as a result, most cancers are not detected until outcomes are poor. The earlier cancer is diagnosed, the better the chance of successful treatment, but cancer can spread and grow before any symptoms arise.
"This study is an important collaborative effort between Alliance and the NCI," said Marie E. Wood, MD, Principal Investigator and Study Chair. Dr. Wood is also Director for Breast Medical Oncology and Director of the Cancer Clinical Trials Office at the University of Colorado. "We hope that quick accrual of a reference set for testing of multicancer early detection assays helps us get to the next level."
The Alliance MCED Biobank Study will contribute to a greater understanding of how to detect multiple types of cancer through early detection blood tests by looking for signals of cancer that may be present. These blood tests (also called liquid biopsies) are designed to identify the presence of multiple cancers before symptoms occur. These tests may be implemented in routine health care to help more people increase their chances of finding cancer early when treatment is more likely to be successful.
Creating this collection of blood samples is one of the initial steps in developing a large clinical trial to evaluate a variety of technologies for cancer screening. We are excited to see the study begin."
Lori M. Minasian, MD, Deputy Director of the National Cancer Institute's Division of Cancer Prevention
The study is currently open to men and women aged 40 to 75 years who are either healthy individuals without cancer, individuals with untreated cancer, or individuals who may have cancer. Individuals with the following cancers at any stage are eligible to participate in the study: bladder, breast, colorectal, endometrial, esophageal, gastric, head or neck, hepatobiliary, kidney, leukemia, lung, lymphoma, melanoma, multiple myeloma, ovarian, pancreatic, prostate, sarcoma, thyroid, or uterine. Individuals must be willing to provide a blood sample and informed consent to participate in the study. In addition, individuals must be able to read and understand English or Spanish.
To facilitate participant engagement and partnership, the Alliance MCED Biobank Study will incorporate a new web-based tool called the Alliance Participant Engagement Portal (PEP). This optional resource will allow participants, their families, and friends, to receive direct updates about the overall progress of the study by either text or e-mail. PEP will also allow participants to self-report their demographics and social determinants of health, which may have an impact on health outcomes, especially for vulnerable populations.
Alliance Group Vice Chair Suzanne George, MD, who led the development of PEP, is excited to deploy it as part of the study. "This tool allows participants to be more engaged and connected in the study as it progresses – for as much or as little as they desire at the time and place that is convenient for them and on their own devices. Participants will receive MCED-specific information and regular study updates, including but not limited to, details on how the study is being done, general information about clinical trials, the informed consent process, the national study team, and much more. The Alliance PEP was created to thank participants for being partners in clinical research."
This study is being conducted by the Alliance for Clinical Trials in Oncology and sponsored by the National Cancer Institute's Division of Cancer Prevention.