Blood and Stool Sample Collection in Subjects Participating in Colorectal Cancer Screening: Act Bold
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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: NCT03821948 |
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Recruitment Status :
Completed
First Posted : January 30, 2019
Last Update Posted : July 21, 2020
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Sponsor:
Exact Sciences Corporation
Information provided by (Responsible Party):
Exact Sciences Corporation
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Brief Summary:
The primary objective of this study is to collect de-identified, clinically-characterized stool and whole blood specimens for use in developing and evaluating the performance of new biomarker assays for detection of colorectal cancer (CRC).
| Condition or disease |
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| Colorectal Cancer |
| Study Type : | Observational |
| Actual Enrollment : | 5131 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Blood and Stool Sample Collection in Subjects Participating in Colorectal Cancer Screening: Act Bold |
| Actual Study Start Date : | January 3, 2019 |
| Actual Primary Completion Date : | February 28, 2020 |
| Actual Study Completion Date : | May 15, 2020 |
Resource links provided by the National Library of Medicine
| Group/Cohort |
|---|
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Average CRC Risk Group
Stool sample collection and blood draw in men and women aged 40 and older with average CRC risk undergoing a standard of care colonoscopy procedure
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Increased CRC Risk Group
Stool sample collection and blood draw in men and women aged 40 and older with increased CRC risk undergoing a standard of care colonoscopy procedure
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Primary Outcome Measures :
- Stool-based biomarkers associated with genetic and epigenetic alterations [ Time Frame: Stool sample will be collected prior to initiation of bowel preparation for colonoscopy. ]The outcomes are co-primary. Biomarkers under evaluation include differential methylation of nucleic acids and altered expression of proteins in stool from subjects at average risk or increased risk for development of colorectal cancer at the pre-intervention stage.
- Blood-based biomarkers associated with genetic and epigenetic alterations. [ Time Frame: Point in time blood collection (1 day) at enrollment. ]The outcomes are co-primary. Biomarkers under evaluation include differential methylation of nucleic acids and altered expression of proteins in blood from subjects at average risk or increased risk for development of colorectal cancer at the pre-intervention stage.
Biospecimen Retention: Samples With DNA
Residual blood and stool samples may be used for evaluating performance of biomarkers for feasibility and assay development. Sample may be stored for up to 20 years. These blood and stool samples will be de-identified.
Information from the National Library of Medicine
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| Ages Eligible for Study: | 40 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Study Population
Subjects will be men and women, 40 years of age or older who are scheduled for a colonoscopy. Approximately 7,500 subjects will be enrolled.
Criteria
Inclusion Criteria:
- Subject is male or female, 40 years of age or older.
- Subject is at average or increased risk for development of CRC.
- Subject presents for screening or surveillance colonoscopy.
- Subject has no symptoms that require immediate, or near term, referral for diagnostic or therapeutic colonoscopy.
- Subject understands the study procedures and is able to provide informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigator.
Exclusion Criteria:
- Any previous cancer diagnosis (with the exceptions of basal cell or squamous cell skin cancers) and/or cancer related treatment (e.g. chemotherapy, immunotherapy, radiation, and/or surgery) within the past 5 years.
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Subject has a diagnosis or personal history of any of the following conditions, including:
- Familial adenomatous polyposis (also referred to as "FAP", including attenuated FAP and Gardner's syndrome).
- Hereditary non-polyposis CRC syndrome (also referred to as "HNPCC" or "Lynch Syndrome").
- Other hereditary cancer syndromes including but are not limited to Peutz-Jeghers Syndrome, MYH-Associated Polyposis (MAP), Turcot's (or Crail's) Syndrome, Cowden's Syndrome, Juvenile Polyposis, Neurofibromatosis and Familial Hyperplastic Polyposis.
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Subject has a family history of:
- Familial adenomatous polyposis (also referred to as "FAP").
- Hereditary non-polyposis CRC syndrome (also referred to as "HNPCC" or "Lynch Syndrome").
- Subjects with Cronkhite-Canada Syndrome.
- IV contrast (e.g. CT and MRI) within 1 day [or 24 hours] of blood collection.
- Subject has any condition that in the opinion of the Investigator should preclude participation in the study
Information from the National Library of Medicine
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): NCT03821948
Locations
Show 40 study locations
Sponsors and Collaborators
Exact Sciences Corporation
| Responsible Party: | Exact Sciences Corporation |
| ClinicalTrials.gov Identifier: | NCT03821948 |
| Other Study ID Numbers: |
2018-08 |
| First Posted: | January 30, 2019 Key Record Dates |
| Last Update Posted: | July 21, 2020 |
| Last Verified: | July 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | Individual participant data that underlie the results reported in publications of the study will be shared after deidentification. This may include text, tables, figures and appendices. The study protocol and informed consent form will also be shared. |
| Supporting Materials: |
Study Protocol Informed Consent Form (ICF) |
| Time Frame: | Data will be available from 2 years and ending 4 years after publication. Data will be shared with researchers who provide a methodologically sound proposal to achieve the aims outlined in the approved proposal. |
| Access Criteria: | Proposals for access to data should be directed to clinicaltrials@exactsciences.com. To gain access, data requestors will need to provide a methodologically sound proposal and sign a data access agreement. Researchers are are required to obtain necessary IRB/EC approvals or waivers as applicable to conduct research. Data will available between 2 and 4 years after publication through the Sponsor. |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
| Product Manufactured in and Exported from the U.S.: | No |
Keywords provided by Exact Sciences Corporation:
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Blood Draw Sample Collection Stool DNA |
Additional relevant MeSH terms:
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Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms |
Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases |