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Trial record 91 of 125 for:    colon cancer AND Rectal | ( Map: New Jersey, United States )

Blood and Stool Sample Collection in Subjects Participating in Colorectal Cancer Screening: Act Bold

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ClinicalTrials.gov Identifier: NCT03821948
Recruitment Status : Recruiting
First Posted : January 30, 2019
Last Update Posted : October 14, 2019
Sponsor:
Information provided by (Responsible Party):
Exact Sciences Corporation

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
Colorectal Cancer

Detailed Description:
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.

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Study Type : Observational
Estimated Enrollment : 7500 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
Estimated Primary Completion Date : February 15, 2020
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine


Group/Cohort
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
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



Primary Outcome Measures :
  1. 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.

  2. 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.
  • Subject has a diagnosis or personal history of any of the following conditions, including:

    1. Familial adenomatous polyposis (also referred to as "FAP", including attenuated FAP and Gardner's syndrome).
    2. Hereditary non-polyposis CRC syndrome (also referred to as "HNPCC" or "Lynch Syndrome").
    3. 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.
  • Subject has a family history of:

    1. Familial adenomatous polyposis (also referred to as "FAP").
    2. 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


Contacts
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Contact: Alexandra Massoud 608-957-5652 amassoud@exactsciences.com
Contact: Julia Zella 608-800-6616 jzella@exactsciences.com

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Sponsors and Collaborators
Exact Sciences Corporation
Investigators
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Study Director: Natalia Voge, MD, PhD Exact Sciences

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Responsible Party: Exact Sciences Corporation
ClinicalTrials.gov Identifier: NCT03821948     History of Changes
Other Study ID Numbers: 2018-08
First Posted: January 30, 2019    Key Record Dates
Last Update Posted: October 14, 2019
Last Verified: October 2019
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.

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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:
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
Colonic Diseases
Rectal Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases