The Alliance for Clinical Trials in Oncology, in partnership with the National Cancer Institute, part of the National Institutes of Health, announced today the opening of a new participant-enrollment study aimed at obtaining a reference set of blood samples from patients newly diagnosed with cancer and healthy individuals without cancer, to be enrolled in a future study to assess the usefulness of blood tests for early detection of cancer.
The Alliance Multicancer Early Detection (MCED) Biobank Study plans to enroll approximately 2,000 people. A blood sample is taken from the participants and they fill out a health questionnaire. Participants with cancer have the opportunity to provide a tissue sample. All participants will be asked to provide another blood sample after one year.
“The Alliance’s MCED reference set and validation of multi-cancer screening assays will create an opportunity for MCED testing to reduce cancer mortality and patient costs of care, improve the effectiveness of cancer screening and 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 for most life-threatening cancers, and as a result, most cancers are not detected until results are poor. The earlier cancer is diagnosed, the greater the chances of successful treatment, but cancer can spread and grow before symptoms appear.
“This study is an important collaborative effort between the Alliance and the NCI,” said Marie E. Wood, MD, Principal Investigator and Study Chair. dr Wood is also Director of Breast Medical Oncology and Director of the Cancer Clinical Trials Office at the University of Colorado. “We hope that the rapid delivery of a reference set for testing multi-cancer screening tests will help us take it to the next level.”
The Alliance MCED Biobank Study will provide a better understanding of how blood tests can detect multiple cancers for early detection by looking for signals of cancers that may be present. These blood tests (also called liquid biopsies) are used to detect the presence of multiple types of cancer before symptoms appear. These tests can be used in routine healthcare to help more people increase their chances of detecting cancer early, when treatment is more likely to be successful.
The creation of this collection of blood samples is one of the first steps in the development of a large clinical trial to evaluate a variety of cancer screening technologies. We look forward to the start of the study.”
Lori M. Minasian, MD, Associate Director, Division of Cancer Prevention, National Cancer Institute
The study is currently open to men and women ages 40 to 75 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, colon, endometrial, esophagus, stomach, head or neck, hepatobiliary, kidney, leukemia, lung, lymphoma, melanoma, multiple myeloma, ovary, pancreas , prostate, sarcoma, thyroid or uterus. Individuals must be willing to provide a blood sample and give their 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 feature a new web-based tool called the Alliance Participant Engagement Portal (PEP). This optional resource allows participants, their families and friends to receive direct updates on the overall progress of the study via SMS or email. PEP will also allow participants to self-report their demographic and social determinants of health, which may impact health outcomes, particularly for vulnerable populations.
Alliance Group Vice Chair Suzanne George, MD, who led the development of PEP, is pleased to use it as part of the study. “This tool allows participants to become more engaged and connected as the study progresses — for as much or as little as they want, 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 was conducted, general information about clinical studies, the consent process, the national study team and much more. The Alliance PEP was created to provide participants with thank their partners in clinical research for their participation.”
This study is being conducted by the Alliance for Clinical Trials in Oncology and sponsored by the Division of Cancer Prevention of the National Cancer Institute.
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Alliance for clinical trials in oncology
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