S-Adenosylmethionine (SAMe) for Chemoprevention of Colorectal Adenomas

ClinicalTrials.gov ID: NCT07582003

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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
Lead sponsor: Jun Gong, MD; Other
Enrollment: 18 participants

Conditions and interventions

Conditions

Interventions

S-Adenosylmethionine (SAMe) Drug

Drug

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: Nov 1, 2026 (Estimated)
Primary completion: Nov 1, 2028 (Estimated)
Completion: Nov 1, 2028 (Estimated)
Last update posted: Aug 4, 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 4, 2026 · Synced Nov 15, 2026