Colorectal CancerNCT05821582
Study SBX-01-101: A Stool Collection Study in Colorectal Cancer (CRC) Patients Treated With Irinotecan-Based Regimens
An observational study of Colorectal Cancer, run by Sanguine Biosciences at 1 site in United States.
Trial summary
The primary objective of the study is to determine whether there is a correlation between the intestinal side effects of chemotherapy treatment and the expression/activity profiles of glucuronidase enzymes in the stool microbiome of the target patient population. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Stool Collection and Survey Completion
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Mar 2023to 5 Oct 2023
- 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 to 85 years
- All sexes
- Adult, Older adult
Study population: Patients with active colorectal cancer
Who may be able to join
- The participant is willing and able to provide written informed consent
- The participant is willing and able to provide appropriate photo identification
- Participants aged 18 to 85, Inclusive
- Participants have been diagnosed with Active Colorectal Cancer (CRC)
- Subjects currently taking irinotecan
Who cannot join
- Participants who are pregnant or are nursing
- Participants with a known history of HIV, hepatitis, or other infectious diseases
- Participants who have taken an investigational product in the last 30 days
- Participants who have experienced excess blood loss, including blood donation, defined as 250 mL in the last month or 500 mL in the previous two months
- Subjects who are currently in remission for CRC.
- Preference (not required for enrollment into study): Exclude subjects currently taking antibiotics*
Trial locations and contacts
1 site in 1 country.
United States1 site
Sanguine Biosciences, Inc.
Woburn, Massachusetts, 01801
About this study
The primary objective of the study is to determine whether there is a correlation between the intestinal side effects of chemotherapy treatment and the expression/activity profiles of glucuronidase enzymes in the stool microbiome of the target patient population.
Read the detailed description
STUDY DESIGN:
- This protocol is a single-center, single-cohort, bioresearch study enrolling up to 8 participants. The cohort is as follows:
- Cohort 1: Colorectal Cancer: (n=8)
- The study will enroll participants per the eligibility criteria.
- Participants will have 2 scheduled at-home stool self-collections at the time points specified in section 4.0 and complete a questionnaire by telephone contact (see section 11.0 for details). The biospecimens collected from participants on this study are stool samples.
- Confirmation of eligibility and medical record review by a member of the study staff will be completed for participants of the disease cohort before they are considered fully enrolled.
- Conditions
- Colorectal Cancer
- Being tested
- Stool Collection and Survey Completion
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stool Collection and Survey CompletionOther
Participants will have 2 scheduled at-home stool self-collections at the time points specified in section 4.0 and complete a questionnaire by telephone contact. The biospecimens collected from participants on this study are stool samples.
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Objective- Intestinal side effects of chemotherapy
The primary objective of the study is to collect stool samples to provide to the sponsor so the sponsor can assess whether there is a correlation between the intestinal side effects of chemotherapy treatment and the expression/activity profiles of glucuronidase enzymes in the stool microbiome of the target patient population.
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2023
- Study start27 Mar 2023
- Primary completion5 Oct 2023
- Study completion5 Oct 2023
Why it stopped: Insufficient recruitment population.
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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanguine Biosciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andrew C Frisina, M.S., Study director, Sanguine Biosciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05821582
- Sponsor's protocol ID
- SAN-09391
- Status last verified
- Oct 2023
- First submitted
- 21 Mar 2023
- Last updated
- 12 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study SBX-01-101: A Stool Collection Study in Colorectal Cancer (CRC) Patients Treated With Irinotecan-Based Regimens
- ClinicalTrials.gov ID
- NCT05821582
- Acronym / sponsor ID
- SAN-09391
- Conditions
- Colorectal Cancer
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Insufficient recruitment population.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Sanguine BiosciencesIndustry (pharma, biotech, devices)
- Study start
- 27 Mar 2023 (actual)
- Primary completion
- 5 Oct 2023 (actual)
- Study completion
- 5 Oct 2023 (actual)
- First posted
- 20 Apr 2023 (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 the study is to determine whether there is a correlation between the intestinal side effects of chemotherapy treatment and the expression/activity profiles of glucuronidase enzymes in the stool microbiome of the target patient population.
Detailed description
STUDY DESIGN:
- This protocol is a single-center, single-cohort, bioresearch study enrolling up to 8 participants. The cohort is as follows:
- Cohort 1: Colorectal Cancer: (n=8)
- The study will enroll participants per the eligibility criteria.
- Participants will have 2 scheduled at-home stool self-collections at the time points specified in section 4.0 and complete a questionnaire by telephone contact (see section 11.0 for details). The biospecimens collected from participants on this study are stool samples.
- Confirmation of eligibility and medical record review by a member of the study staff will be completed for participants of the disease cohort before they are considered fully enrolled.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with active colorectal cancer
Key inclusion criteria (5 listed)
- The participant is willing and able to provide written informed consent
- The participant is willing and able to provide appropriate photo identification
- Participants aged 18 to 85, Inclusive
- Participants have been diagnosed with Active Colorectal Cancer (CRC)
- Subjects currently taking irinotecan
Key exclusion criteria (6 listed)
- Participants who are pregnant or are nursing
- Participants with a known history of HIV, hepatitis, or other infectious diseases
- Participants who have taken an investigational product in the last 30 days
- Participants who have experienced excess blood loss, including blood donation, defined as 250 mL in the last month or 500 mL in the previous two months
- Subjects who are currently in remission for CRC.
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 Collection and Survey CompletionParticipants will have 2 scheduled at-home stool self-collections at the time points specified in section 4.0 and complete a questionnaire by telephone contact. The biospecimens collected from participants on this study are stool samples. | Other | – |
Primary outcome
Primary Objective- Intestinal side effects of chemotherapy
Time frame: 8 months
The primary objective of the study is to collect stool samples to provide to the sponsor so the sponsor can assess whether there is a correlation between the intestinal side effects of chemotherapy treatment and the expression/activity profiles of glucuronidase enzymes in the stool microbiome of the target patient population.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2023.
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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.
Andrew C Frisina, M.S. study director
Sanguine Biosciences
1 site 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 Sanguine Biosciences at 1 site 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 5 inclusion and 6 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: withdrawn, as of the sponsor's last update on 12 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 was withdrawn before enrolling participants, so there are no results.
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?
Primary Objective- Intestinal side effects of chemotherapy (time frame: 8 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 12 Oct 2023.