Stool Sample Collection Study

February 28, 2024 updated by: Innovis LLC

Stool Sample Collection Study for Colorectal Cancer Test Research and Development

The primary objective of this study is to obtain de-identified stool specimens from participants with colonoscopic biopsy-based histopathologic diagnosis of colorectal cancer (CRC) and/or a ≥1 cm colorectal polyp/adenoma/mass found during pre-enrollment colonoscopy that is of sufficient size to require surgical excision or complex colonoscopic polypectomy.

The samples will be used for the purpose of research and development of a new molecular diagnostic test for the detection of neoplasms of the aerodigestive tract.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Participants providing written informed consent to participate in the study will be provided with a stool collection kit with multiple components. Participants will perform whole stool collection at home using a standardized whole stool collection device designed to fit over the toilet seat. The kit will also include a small, white-capped collection tube which participants will be instructed to use to collect a stool sample from the whole stool to allow for a fecal immunochemical test (FIT). In addition, the kit will contain an investigational device that includes a collection scoop and buffering solution. The investigational device will be used by participants to collect a stool sample from the whole stool. After the two (2) samples are collected from the whole stool, a buffering solution will then be poured over the remaining whole stool. The residual buffered whole stool, the sample in the small, white-capped collection tube (FIT) and the partial stool sample in the investigational collection device will be returned to the Sponsor in a self-shipping box, per the instructions provided to the participants.

All stool samples will be provided ≥7 days post-colonoscopy and prior to initiating bowel preparation for surgery, and/or neoadjuvant chemotherapy, radiation therapy, and/or follow-up therapeutic colonoscopy.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • California
      • Anaheim, California, United States, 92810
        • Recruiting
        • Associated Gastroenterology Medical Group
        • Contact:
        • Principal Investigator:
          • Brian Riff, MD
    • Florida
      • Ocala, Florida, United States, 34474
        • Recruiting
        • Sarkis Clinical Trials
        • Principal Investigator:
          • Vishnu Reddy, MD
        • Contact:
    • Tennessee
      • Cordova, Tennessee, United States, 38018
        • Recruiting
        • Gastro One
        • Principal Investigator:
          • Ziad Younes, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Men and women 18 years or greater with a diagnosis of CRC, at any stage, or ≥1 cm colorectal polyp/adenoma/mass found during pre-enrollment colonoscopy that is of sufficient size to require surgical excision or complex colonoscopic polypectomy.

Description

Inclusion Criteria:

  1. Participant is a person ≥18 years of age.
  2. Participant has a diagnosis of CRC, at any stage, or ≥1 cm colorectal polyp/adenoma/mass found during pre-enrollment colonoscopy that is of sufficient size to require surgical excision or complex colonoscopic polypectomy.
  3. Participant understands the study procedures and can provide informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigator.

Exclusion Criteria:

  1. Participant has actively bleeding hemorrhoids.
  2. Participant has active synchronous extra-colonic aerodigestive tract cancers (e.g., lung, esophagus, stomach, or pancreatic cancer).
  3. Participant has a prior history of extra-colonic aerodigestive tract malignancy within the past 5 years.
  4. Participant has a history of any inflammatory bowel disease.
  5. Participant has familial adenomatous polyposis, hereditary non-polyposis colorectal cancer (Lynch) syndrome, or other hereditary cancer syndromes.
  6. Participant has benign (non-pre-cancerous) polyps such as inflammatory polyps or hamartoma polyps.

  7. Individual has a condition the Investigator believes would interfere with their ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results or put the person at undue risk.

    -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Detection of colon cancer or precancer
Time Frame: 10 months
To provide stool specimens to Exact Sciences to allow for additional research and development of a screening device for the detection of colorectal and other aerodigestive tract cancers.
10 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Innovis LLC

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Exact Sciences Corporation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Gregg S Britt, Innovis LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 20, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 28, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 28, 2024

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 6, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 6, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 28, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Innovis RD-2301

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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