BridgeMD
New treatment option for Adenocarcinoma of the Colon
Official title Five or Ten Year Colonoscopy for 1-2 Non-Advanced Adenomatous Polyps
ClinicalTrials.gov ID: NCT05080673
What this study is testing
- What it's testing
- This trial examines colorectal cancer incidence in participants with 1 to 2 non-advanced adenomas randomized to surveillance colonoscopy at 10 years compared to participants randomized to surveillance colonoscopy at 5 and 10 years.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 45 to 70
You may be able to join if
- The participant must have signed and dated an IRB-approved consent form that conforms to federal and institutional guidelines.
- Participants greater than or equal to 45 and less than 70 years of age at the time of colonoscopy.
- Participants with a first-time diagnosis of 1-2 non-advanced tubular adenomas (less than 10 mm without tubulovillous or villous changes or high grade...
- Sessile serrated polyps/adenomas, as long as they do not meet the criteria for advanced adenomas, will be considered as non-advanced adenomas.
- Qualifying colonoscopy must be a complete colonoscopy with visualization of the cecum and with adequate cleansing within 4 years prior to...
You likely can't join if
- Prior history of colorectal cancer or colorectal adenomas including sessile serrated polyps/adenomas excluding those found on the qualifying...
- Prior history of a hyperplastic polyp measuring greater than or equal to 1 cm in size.
- Traditional serrated adenomas found on the qualifying colonoscopy.
- Hyperplastic polyp measuring greater than or equal to 1 cm in size found on the qualifying colonoscopy.
- Previous malignancies unless the patient has been disease-free for 5 or more years prior to randomization and is deemed by the physician to be at low...
- Colonoscopy performed after the qualifying colonoscopy but prior to randomization.
See the full eligibility criteria
- The participant must have signed and dated an IRB-approved consent form that conforms to federal and institutional guidelines.
- Participants greater than or equal to 45 and less than 70 years of age at the time of colonoscopy.
- Participants with a first-time diagnosis of 1-2 non-advanced tubular adenomas (less than 10 mm without tubulovillous or villous changes or high grade or severe dysplasia) from the qualifying colonoscopy within 4 years...
- Sessile serrated polyps/adenomas, as long as they do not meet the criteria for advanced adenomas, will be considered as non-advanced adenomas.
- Qualifying colonoscopy must be a complete colonoscopy with visualization of the cecum and with adequate cleansing within 4 years prior to randomization.
- Complete excision of all observed polyps in qualifying colonoscopy
- Participants must be able to read or understand English or Spanish.
- Prior history of colorectal cancer or colorectal adenomas including sessile serrated polyps/adenomas excluding those found on the qualifying colonoscopy.
- Prior history of a hyperplastic polyp measuring greater than or equal to 1 cm in size.
- Traditional serrated adenomas found on the qualifying colonoscopy.
- Hyperplastic polyp measuring greater than or equal to 1 cm in size found on the qualifying colonoscopy.
- Previous malignancies unless the patient has been disease-free for 5 or more years prior to randomization and is deemed by the physician to be at low risk for recurrence. Patients with the following cancers are eligible...
- Colonoscopy performed after the qualifying colonoscopy but prior to randomization.
- Incomplete qualifying colonoscopy (e.g., cecum not visualized).
- Incomplete endoscopic excision of adenomatous polyps based on colonoscopist impression at qualifying colonoscopy. (Excision of all hyperplastic rectosigmoid polyps is not required.)
- Sub-total colectomy or total proctocolectomy. (Segmental resections are allowed.)
- Family history of CRC diagnosed at less than or equal to 60 years of age in a first degree relative (mother, father, child, sibling) or in two first degree relatives with CRC at any age.
- Participants with a clinical diagnosis of a significant heritable risk for colorectal cancer (Familial Adenomatous Polyposis, Hereditary Nonpolyposis Colorectal Cancer [Lynch Syndrome]).
- Participants tested positive for a Familial Adenomatous Polyposis, Hereditary Nonpolyposis Colorectal Cancer [Lynch Syndrome] genetic mutation that increases risk of colorectal cancer.
- Inflammatory bowel disease (e.g., Crohn's Disease, ulcerative colitis).
- Life expectancy less than 10 years due to comorbid conditions in the opinion of the investigator.
- Other comorbid conditions that would prevent the participant from having colonoscopies or would prevent required follow-up.
The study team makes the final eligibility decision.
Where it's taking place
- Fairbanks, Alaska, United States
- Goodyear, Arizona, United States
- Kingman, Arizona, United States
- Phoenix, Arizona, United States
- Tucson, Arizona, United States
- Fort Smith, Arkansas, United States
- Hot Springs, Arkansas, United States
- Little Rock, Arkansas, United States
- Anaheim, California, United States
- Arroyo Grande, California, United States
- Baldwin Park, California, United States
- Bellflower, California, United States
- Carmichael, California, United States
- Dublin, California, United States
- Elk Grove, California, United States
- Emeryville, California, United States
- Fontana, California, United States
- Harbor City, California, United States
- Irvine, California, United States
- Los Angeles, California, United States
+ 309 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 45 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Fairbanks, Alaska, United States; Goodyear, Arizona, United States; Kingman, Arizona, United States; Phoenix, Arizona, United States; Tucson, Arizona, United States; Fort Smith, Arkansas, United States and 323 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.