Colorectal CancerNCT04473625
Stool Collection Sub-Study of Exact Sciences Protocol 2018-01
An observational study of Colorectal Cancer and Colo-rectal Cancer, run by Exact Sciences Corporation at 12 sites in United States.
Trial summary
The primary objective of this sub-study is to obtain de-identified, clinically characterized, stool specimens from subjects with untreated solid tumors for research use in the development and validation of a stool-based test for colorectal cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Colo-rectal Cancer, Cancer
- What is being tested?
- Stool Sample Collection
- How many people
- 291 participants
- Where
- 12 sitesUnited States
- Study dates
- 21 Jul 2020to 25 May 2022
- 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: Subjects will be men and women, 18 years of age or older, who enroll in Exact Sciences Protocol 2018-01. Approximately 450 subjects will be enrolled.
Who may be able to join
- Subject is currently enrolled in Exact Sciences Protocol 2018-01.
- Subject is willing and able to provide a stool sample.
- Subject understands the study procedures and is able to provide written informed consent to participate in the study.
Who cannot join
- Subject has a condition the Investigator believes would interfere with his or her ability to provide informed consent, comply with the sub-study protocol, or put the person at undue risk.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
CAMC Clinical Trials Center
Charleston, West Virginia, 25304
Marin Cancer Care
Greenbrae, California, 94904
Cone Health Cancer Center
Greensboro, North Carolina, 27403
Genesis Cancer Center
Hot Springs, Arkansas, 71913
St. Dominic's Gynecologic Oncology
Jackson, Mississippi, 39216
The Jackson Clinic
Jackson, Tennessee, 38301
CSNF- Central Business Office
Jacksonville, Florida, 32256
CARTI Cancer Center
Little Rock, Arkansas, 72205
Easter Ct Hematology
Norwich, Connecticut, 06360
Community Cancer Trials of Utah
Ogden, Utah, 84405
Park Nicollet Institute - Oncology Research
Saint Louis Park, Minnesota, 55426
Arizona Clinical Research Center, Inc.
Tucson, Arizona, 85715
About this study
Official title: Stool Collection Sub-Study of Exact Sciences Protocol 2018-01: "Blood Sample Collection to Evaluate Biomarkers in Subjects With Untreated Solid Tumors
The primary objective of this sub-study is to obtain de-identified, clinically characterized, stool specimens from subjects with untreated solid tumors for research use in the development and validation of a stool-based test for colorectal cancer.
- Conditions
- Colorectal Cancer, Colo-rectal Cancer, Cancer
- Being tested
- Stool Sample Collection
- Keywords
- Colorectal Cancer, Cologuard, Sample Collection
- Medical subject headings
- Colorectal Neoplasms, Colonic Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stool Sample CollectionOther
Subjects participating in the study will provide a stool sample within 30 days of enrollment.
| Study group | Role | What they receive |
|---|---|---|
| Breast | Subjects with clinically confirmed breast cancer and who are treatment naive will provide a stool sample within 30 days of enrollment. No additional stool sample collections will occur. Receives: Other: Stool Sample Collection | |
| Lung | Subjects with clinically confirmed lung cancer and who are treatment naive will provide a stool sample within 30 days of enrollment. No additional stool sample collections will occur. Receives: Other: Stool Sample Collection | |
| Colorectal | Subjects with clinically confirmed colorectal cancer and who are treatment naive will provide a stool sample within 30 days of enrollment. No additional stool sample collections will occur. Receives: Other: Stool Sample Collection | |
| Prostate | Subjects with clinically confirmed prostate cancer and who are treatment naive will provide a stool sample within 30 days of enrollment. No additional stool sample collections will occur. Receives: Other: Stool Sample Collection | |
| Bladder | Subjects with clinically confirmed or suspicion of bladder cancer and who are treatment naive will provide a stool sample within 30 days of enrollment. No additional stool sample collections will occur. Receives: Other: Stool Sample Collection | |
| Uterine | Subjects with clinically confirmed uterine cancer and who are treatment naive will provide a stool sample within 30 days of enrollment. No additional stool sample collections will occur. Receives: Other: Stool Sample Collection | |
| Kidney/Renal Pelvis | Subjects with clinically confirmed or suspicion of kidney/renal pelvis cancer and who are treatment naive will provide a stool sample within 30 days of enrollment. No additional stool sample collections will occur. Receives: Other: Stool Sample Collection | |
| Ovarian | Subjects with clinically confirmed or suspicion of ovarian cancer and who are treatment naive will provide a stool sample within 30 days of enrollment. No additional stool sample collections will occur. Receives: Other: Stool Sample Collection | |
| Liver | Subjects with clinically confirmed liver cancer and who are treatment naive will provide a stool sample within 30 days of enrollment. No additional stool sample collections will occur. Receives: Other: Stool Sample Collection | |
| Pancreas | Subjects with clinically confirmed or suspicion of pancreatic cancer and who are treatment naive will provide a stool sample within 30 days of enrollment. No additional stool sample collections will occur. Receives: Other: Stool Sample Collection | |
| Stomach | Subjects with clinically confirmed stomach cancer and who are treatment naive will provide a stool sample within 30 days of enrollment. No additional stool sample collections will occur. Receives: Other: Stool Sample Collection | |
| Esophageal | Subjects with clinically confirmed esophageal cancer and who are treatment naive will provide a stool sample within 30 days of enrollment. No additional stool sample collections will occur. Receives: Other: Stool Sample Collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stool-based test for colorectal cancer
Research for the development and validation of a stool-based test for colorectal cancer
Measured: Point in time (one day) stool collection within 30 days of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2020
- Study start21 Jul 2020
- Primary completion31 Mar 2022
- Study completion25 May 2022
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
- 291 participants (actual)
Sponsor and investigators
- Lead sponsor
- Exact Sciences Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04473625
- Sponsor's protocol ID
- 2018-01B
- Status last verified
- Jun 2022
- First submitted
- 13 Jul 2020
- Last updated
- 6 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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 (when applicable) will also be shared.
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stool Collection Sub-Study of Exact Sciences Protocol 2018-01: "Blood Sample Collection to Evaluate Biomarkers in Subjects With Untreated Solid Tumors
- ClinicalTrials.gov ID
- NCT04473625
- Acronym / sponsor ID
- 2018-01B
- Conditions
- Colorectal Cancer, Colo-rectal Cancer, Cancer
- Keywords
- Colorectal Cancer, Cologuard, Sample Collection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 291 participants (actual)
- Lead sponsor
- Exact Sciences CorporationIndustry (pharma, biotech, devices)
- Study start
- 21 Jul 2020 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 25 May 2022 (actual)
- First posted
- 16 Jul 2020 (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 sub-study is to obtain de-identified, clinically characterized, stool specimens from subjects with untreated solid tumors for research use in the development and validation of a stool-based test for colorectal cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 12
| Arm | Type | Receives |
|---|---|---|
| Breast | – | Other: Stool Sample CollectionSubjects with clinically confirmed breast cancer and who are treatment naive will provide a stool sample within 30 days of enrollment. No additional stool sample collections will occur. |
| Lung | – | Other: Stool Sample CollectionSubjects with clinically confirmed lung cancer and who are treatment naive will provide a stool sample within 30 days of enrollment. No additional stool sample collections will occur. |
| Colorectal | – | Other: Stool Sample CollectionSubjects with clinically confirmed colorectal cancer and who are treatment naive will provide a stool sample within 30 days of enrollment. No additional stool sample collections will occur. |
| Prostate | – | Other: Stool Sample CollectionSubjects with clinically confirmed prostate cancer and who are treatment naive will provide a stool sample within 30 days of enrollment. No additional stool sample collections will occur. |
| Bladder | – | Other: Stool Sample CollectionSubjects with clinically confirmed or suspicion of bladder cancer and who are treatment naive will provide a stool sample within 30 days of enrollment. No additional stool sample collections will occur. |
| Uterine | – | Other: Stool Sample CollectionSubjects with clinically confirmed uterine cancer and who are treatment naive will provide a stool sample within 30 days of enrollment. No additional stool sample collections will occur. |
| Kidney/Renal Pelvis | – | Other: Stool Sample CollectionSubjects with clinically confirmed or suspicion of kidney/renal pelvis cancer and who are treatment naive will provide a stool sample within 30 days of enrollment. No additional stool sample collections will occur. |
| Ovarian | – | Other: Stool Sample CollectionSubjects with clinically confirmed or suspicion of ovarian cancer and who are treatment naive will provide a stool sample within 30 days of enrollment. No additional stool sample collections will occur. |
| Liver | – | Other: Stool Sample CollectionSubjects with clinically confirmed liver cancer and who are treatment naive will provide a stool sample within 30 days of enrollment. No additional stool sample collections will occur. |
| Pancreas | – | Other: Stool Sample CollectionSubjects with clinically confirmed or suspicion of pancreatic cancer and who are treatment naive will provide a stool sample within 30 days of enrollment. No additional stool sample collections will occur. |
| Stomach | – | Other: Stool Sample CollectionSubjects with clinically confirmed stomach cancer and who are treatment naive will provide a stool sample within 30 days of enrollment. No additional stool sample collections will occur. |
| Esophageal | – | Other: Stool Sample CollectionSubjects with clinically confirmed esophageal cancer and who are treatment naive will provide a stool sample within 30 days of enrollment. No additional stool sample collections will occur. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects will be men and women, 18 years of age or older, who enroll in Exact Sciences Protocol 2018-01. Approximately 450 subjects will be enrolled.
Key inclusion criteria (3 listed)
- Subject is currently enrolled in Exact Sciences Protocol 2018-01.
- Subject is willing and able to provide a stool sample.
- Subject understands the study procedures and is able to provide written informed consent to participate in the study.
Key exclusion criteria (1 listed)
- Subject has a condition the Investigator believes would interfere with his or her ability to provide informed consent, comply with the sub-study protocol, or put the person at undue risk.
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 |
|---|---|---|
| Stool Sample CollectionSubjects participating in the study will provide a stool sample within 30 days of enrollment. | Other | Bladder, Breast, Colorectal, Esophageal, Kidney/Renal Pelvis, Liver, Lung, Ovarian, Pancreas, Prostate, Stomach, Uterine |
Primary outcome
Stool-based test for colorectal cancer
Time frame: Point in time (one day) stool collection within 30 days of enrollment
Research for the development and validation of a stool-based test for colorectal cancer
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2022.
- Individual participant dataSharing planned: Yes. 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 (when applicable) will also be shared.
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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.
The record lists no contact. Use the official record to reach the sponsor.
12 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 and Colo-rectal Cancer, run by Exact Sciences Corporation at 12 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 1 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: finished, as of the sponsor's last update on 6 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stool-based test for colorectal cancer (time frame: Point in time (one day) stool collection within 30 days of enrollment). 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 Jun 2022.