S-Adenosylmethionine (SAMe) for Chemoprevention of Colorectal Adenomas
Public ClinicalTrials.gov record NCT07582003. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase I Trial of S-Adenosylmethionine (SAMe) for Chemoprevention of Colorectal Adenomas
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study will enroll a total of 18 patients who have undergone curative surgery for stage I or II colorectal cancer and are planned for post-surgical surveillance without any need for chemotherapy at Cedars-Sinai Medical Center. All subjects will receive an oral daily supplement called S-Adenosylmethionine (SAMe) which has been hypothesized to reduce colorectal polyps (precursors to colorectal cancer) and prevent colorectal cancer formation. The study investigates what the appropriate dosage of SAMe is so that there is the lowest risk of side effects, and whether the supplement will prevent polyp formation in a population of patients who at risk for developing polyps and colorectal cancer. The primary endpoint will be to determine the recommended phase II dose (RP2D), the highest safe dose of SAMe that could be studied in larger clinical trials to advance this agent further in clinical development. Secondary endpoints include safety, the rate of postoperative adenomas detected on surveillance colonoscopy, and the effects of SAMe on the colon, specifically, its impact on gut bacteria and tissue markers before and after SAMe treatment to better understand the mechanisms to how SAMe may have its colorectal cancer preventive effects.
Study identification
- NCT ID
- NCT07582003
- Recruitment status
- Not yet recruiting
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 18 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 31, 2026
- Primary completion
- Oct 31, 2028
- Completion
- Oct 31, 2028
- Last update posted
- Aug 3, 2026
2026 – 2028
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07582003, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 3, 2026 · Synced Sep 24, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07582003 live on ClinicalTrials.gov.