Detecting Cancers Earlier Through Elective Plasma-based CancerSEEK Testing (ASCEND)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT04213326 |
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Recruitment Status :
Completed
First Posted : December 30, 2019
Results First Posted : January 18, 2023
Last Update Posted : January 18, 2023
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This is a prospective, observational study of 1,000 subjects with known or suspected cancer and 2,000 subjects with no known cancer.
Potential participants will be asked questions to confirm their eligibility by a nurse navigator, study staff member, or physician.
Informed consent will be carried out for eligible subjects in accordance with applicable federal regulations and International Council for Harmonisation (ICH)/Good Clinical Practice (GCP) guidelines.
Subjects will then complete a survey, and study staff will draw 60 mL of blood and measure the height and weight of the subject.
Where available, data from the medical records of the cancer subjects will reviewed and collected. In addition, non-cancer subjects will be requested to allow access to their medical records as an optional portion of their informed consent.
| Condition or disease |
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| Early Cancer Detection |
This is a prospective, observational study of 1,000 subjects with known or suspected cancer confirmed through pathology reports and/or clinical/radiographic data and 2,000 subjects with no known cancer. De-identified blood samples and clinical data will be collected from subjects to validate a classification algorithm for a new version of the CancerSEEK assay.
Potential participants will be asked questions to confirm their eligibility by a nurse navigator, study staff member, or physician to document screening including date of upcoming therapy or surgery for cancer patients if one has been scheduled, before providing informed consent to participate in the study. Study procedures outside of the pre-screening for eligibility will not be performed prior to the subject providing consent. Informed consent will be carried out in accordance with applicable federal regulations and International Council for Harmonisation (ICH)/Good Clinical Practice (GCP) guidelines. Prior to signing the informed consent form (ICF), potential participants will confirm that they understand the study and that they have no questions about the study.
The ICF may be offered by paper or electronically with the option to also review a paper copy provided by the nurse navigator or study coordinator either face-to-face on a tablet or via email. Potential participants will be given a phone number to call with any study specific questions. Copies of all signed consent forms will be stored centrally in a secure environment, and signed consent forms will thereby be available for verification by Thrive or its designee at any time.
Once the subject completes the survey, study staff will complete the blood draw and collect height and weight data. For some participants, their contact information and unique study identifier (ID) will be sent securely to a third-party vendor who will contact the subject within 24 hours to schedule the blood draw and height and weight measurements at a location convenient to the subject.
For all subjects, study staff and the third-party vendor performing the blood collection will verify the following before performing the blood draw and height and weight measurements: participant identity and age against a form of identification, that consent to participate has been given, that the participants in the cancer arm are still treatment naïve, and that they do not have a fever that could be caused by an infection. The blood collection vendor will ensure all required data are captured and included with the blood sample, that the sample is collected and packaged according to laboratory manual specifications, and that the sample is shipped to the indicated processing lab with the required expediency. Following all study visits, study staff and third party vendor staff will complete a visit checklist confirming all of the study activities that occurred.
Subjects in the Cancer cohort will be identified via nurse navigation, study staff or oncology physicians in local offices. The nurse navigator or study staff will verify eligibility through chart review and pre-screen, approach the subject about the study opportunity, and present the informed consent form. For participants enrolling electronically, participants will be presented with a secured tablet device on which the subject will watch a brief video about the study, read the informed consent and provide electronic consent. Some participants may also have the option of having the video, informed consent and survey emailed to them. Upon consent and enrollment, subjects will be assigned a unique subject study ID, which will be used to track the subject, their data and their biospecimen throughout study operations. Consented subjects will then be directed to complete a survey via the tablet device, email or paper. Participants will be allowed to skip questions in the survey or select the answer option "prefer not to answer." Subject data will be tracked in real-time by central study staff to ensure desired tumor type diversification and communicate enrollment strategy changes to the nurse navigators and study staff.
| Study Type : | Observational |
| Actual Enrollment : | 6400 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Detecting Cancers Earlier Through Elective Plasma-based CancerSEEK Testing - Ascertaining Serial Cancer Patients to Enable New Diagnostic |
| Actual Study Start Date : | November 18, 2019 |
| Actual Primary Completion Date : | January 29, 2021 |
| Actual Study Completion Date : | January 29, 2021 |
| Group/Cohort |
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Cancer Cohort
Subjects interested in the cancer cohort, will sign an informed consent, complete an optional survey, and have 60mLs of blood draw by a licensed phlebotomist.
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Non-Cancer Cohort
Subjects interested in the non-cancer cohort, will sign an informed consent, complete an optional survey, and have 60mLs of blood draw by a licensed phlebotomist.
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- Study Data and Samples Were Used for CancerSEEK Assay Development [ Time Frame: 6 months ]The primary objective of the study is to collect blood samples from known cancer and non cancer participants. These blood samples were used to calibrate the CancerSEEK assay. There was no pre-defined performance threshold.
Biospecimen Retention: Samples With DNA
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 50 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Probability Sample |
Inclusion Criteria:
- Age 50 or greater
- Ability to understand the nature of this study and give written informed consent
CANCER COHORT:
Either of the following:
- Histologic diagnosis of cancer with no prior systemic or definitive therapy (any stage, including, inclusive of is-situ carcinoma)
Or
- Subject with high suspicion of cancer through radiological and/or clinical assessment who are scheduled for resection or biopsy within 6 weeks of study blood collection and have not received prior systemic or definitive therapy.
NON-CANCER COHORT
- No prior history of cancer
Exclusion Criteria:
ALL PATIENTS
- Evidence of active febrile infection prior to blood draw.
- Women who are pregnant or breast-feeding.
- History of an allogeneic bone marrow, stem cell transplant, or solid organ transplant.
- Judgment by the Investigator or study staff of any other reason that would prohibit the inclusion of the subject in the study.
CANCER COHORT
- Subjects newly diagnosed with a hematologic malignancy, primary central nervous system tumor, prostate cancer, or skin cancer (including melanoma).
- History of, or currently receiving, systemic or definitive cancer treatment including curative surgical resection, chemotherapy, radiation therapy, immunotherapy, and hormone therapy.
NON-CANCER COHORT
• None
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04213326
| United States, California | |
| Sarah Cannon | |
| Thousand Oaks, California, United States, 23229 | |
| United States, Colorado | |
| Sarah Cannon | |
| Denver, Colorado, United States, 80220 | |
| United States, Florida | |
| Sarah Cannon | |
| Fort Walton Beach, Florida, United States, 32547 | |
| Sarah Cannon | |
| Ocala, Florida, United States, 34471 | |
| Sarah Cannon | |
| Pensacola, Florida, United States, 32514 | |
| United States, Georgia | |
| Sarah Cannon | |
| Augusta, Georgia, United States, 30909 | |
| Sarah Cannon | |
| Macon, Georgia, United States, 31217 | |
| Sarah Cannon | |
| Savannah, Georgia, United States, 31404 | |
| United States, Kansas | |
| Sarah Cannon | |
| Kansas City, Kansas, United States, 64012 | |
| Sarah Cannon | |
| Overland Park, Kansas, United States, 66209 | |
| United States, Missouri | |
| Sarah Cannon | |
| Independence, Missouri, United States, 64057 | |
| United States, Nevada | |
| Sarah Cannon | |
| Las Vegas, Nevada, United States, 89129 | |
| United States, Tennessee | |
| Sarah Cannon | |
| Nashville, Tennessee, United States, 37203 | |
| United States, Virginia | |
| Sarah Cannon | |
| Richmond, Virginia, United States, 23229 | |
| Principal Investigator: | Dax Kurbegov, MD | Sarah Cannon |
Documents provided by Exact Sciences Corporation:
| Responsible Party: | Exact Sciences Corporation |
| ClinicalTrials.gov Identifier: | NCT04213326 |
| Other Study ID Numbers: |
HEOR 24 |
| First Posted: | December 30, 2019 Key Record Dates |
| Results First Posted: | January 18, 2023 |
| Last Update Posted: | January 18, 2023 |
| Last Verified: | April 2022 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |