Colorectal CancerNCT06294873
Stool Sample Collection Study
An observational study of Colorectal Cancer, run by Innovis LLC at 3 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- A screening device for the detection of colorectal and other aerodigestive tract cancers
- How many people
- 40 participants
- Where
- 3 sitesUnited States
- Study dates
- 20 Jul 2023to 30 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Participant is a person ≥18 years of age.
- 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.
- 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.
Who cannot join
- Participant has actively bleeding hemorrhoids.
- Participant has active synchronous extra-colonic aerodigestive tract cancers (e.g., lung, esophagus, stomach, or pancreatic cancer).
- Participant has a prior history of extra-colonic aerodigestive tract malignancy within the past 5 years.
- Participant has a history of any inflammatory bowel disease.
- Participant has familial adenomatous polyposis, hereditary non-polyposis colorectal cancer (Lynch) syndrome, or other hereditary cancer syndromes.
- Participant has benign (non-pre-cancerous) polyps such as inflammatory polyps or hamartoma polyps.
- 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.
- -
Trial locations and contacts
3 sites in 1 country.
United States3 sites, 3 recruiting
- Recruiting
Associated Gastroenterology Medical Group
Anaheim, California, 92810
Brian Riff, MD, 714-778-1300 ext. 227, briff@agmg.com
Brian Riff, MD
- Recruiting
Gastro One
Cordova, Tennessee, 38018
Brian Dragutsky, 901-606-8924, brian.dragutsky@onegi.com
Ziad Younes, MD
- Recruiting
Sarkis Clinical Trials
Ocala, Florida, 34474
Jen Corcoran, 352-363-5395 ext. 272, merci@ehsfamily.com
Vishnu Reddy, MD
About this study
Official title: 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.
Read the 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.
- Conditions
- Colorectal Cancer
- Being tested
- A screening device for the detection of colorectal and other aerodigestive tract cancers
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A screening device for the detection of colorectal and other aerodigestive tract cancersDiagnostic test
DNA test to screen to detect colon cancer and precancerous lesions
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of colon cancer or precancer
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.
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2024
- Study start20 Jul 2023
- Primary completion30 Apr 2024 (estimated)
- Study completion30 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Innovis LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Exact Sciences Corporation
- Responsible party
- Sponsor
- Investigators
- Gregg S Britt, Study director, Innovis LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06294873
- Sponsor's protocol ID
- Innovis RD-2301
- Status last verified
- Feb 2024
- First submitted
- 28 Feb 2024
- Last updated
- 6 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stool Sample Collection Study for Colorectal Cancer Test Research and Development
- ClinicalTrials.gov ID
- NCT06294873
- Acronym / sponsor ID
- Innovis RD-2301
- Conditions
- Colorectal Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Innovis LLCIndustry (pharma, biotech, devices)
- Collaborators
- Exact Sciences Corporation
- Study start
- 20 Jul 2023 (actual)
- Primary completion
- 30 Apr 2024 (estimated)
- Study completion
- 30 Apr 2024 (estimated)
- First posted
- 6 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Participant is a person ≥18 years of age.
- 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.
- 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.
Key exclusion criteria (8 listed)
- Participant has actively bleeding hemorrhoids.
- Participant has active synchronous extra-colonic aerodigestive tract cancers (e.g., lung, esophagus, stomach, or pancreatic cancer).
- Participant has a prior history of extra-colonic aerodigestive tract malignancy within the past 5 years.
- Participant has a history of any inflammatory bowel disease.
- Participant has familial adenomatous polyposis, hereditary non-polyposis colorectal cancer (Lynch) syndrome, or other hereditary cancer syndromes.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A screening device for the detection of colorectal and other aerodigestive tract cancersDNA test to screen to detect colon cancer and precancerous lesions | Diagnostic test | – |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gregg S Britt study director
Innovis LLC
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer, run by Innovis LLC at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wallis S Blumm (9172082989, wblumm@innovis.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of colon cancer or precancer (time frame: 10 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2024.