Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSF
Dates
study started
completion around
Principal Investigator
by Aparajita Singh,, MD (ucsf)
Headshot of Aparajita Singh
Aparajita Singh

Description

Summary

This study collects blood and stool samples from patients with suspected or diagnosed Lynch syndrome to evaluate a deoxyribonucleic acid (DNA) screening technique for the detection of colorectal cancer in Lynch syndrome patients.

Official Title

Detection of Colorectal Cancer or Advanced Neoplasia by Stool DNA in Lynch Syndrome: CORAL Study

Details

PRIMARY OBJECTIVE:

  1. To determine the sensitivity and specificity of the multitarget stool DNA (mt-sDNA) 2.0 test, for colorectal neoplasia in patients with Lynch syndrome.

SECONDARY OBJECTIVE:

  1. Develop a biorepository of samples (stool and blood) from patients with Lynch syndrome and early onset (< 50 years old) colorectal cancer.

OUTLINE:

Patients undergo collection of blood and stool samples no more than 90 days prior to or between 7-90 days after standard of care colonoscopy or flexible sigmoidoscopy. Patients' medical records are also reviewed.

Keywords

Colorectal Carcinoma, Lynch Syndrome, Colorectal Neoplasms, Hereditary Nonpolyposis Colorectal Neoplasms, Syndrome, Biospecimen Collection, Electronic Health Record Review

Eligibility

You can join if…

Open to people ages 18 years and up

  • Patients at least 18 years of age
  • Individuals diagnosed with Lynch syndrome (mutation in MLH1, MSH2, MSH6, PMS2, EPCAM) or suspected Lynch syndrome or individuals diagnosed with early onset colorectal cancer (CRC) (< 50 years old)
  • Colonoscopy/flexible sigmoidoscopy (flex sig) scheduled +/- 90 days from sample collection
  • Patient has agreed to participate and has signed the study consent form

You CAN'T join if...

  • Patient has known cancer (stage I-IV) 5 years prior to current sample collection (not including basal cell or squamous cell skin cancers; if patient has not been seen or if information is not available, the patient is eligible)
  • Patient has received chemotherapy class drugs for the treatment of cancer in the 5 years prior to current sample collection
  • Patient has had any abdominal radiation therapy prior to current sample collection
  • Patient had therapy to the target lesion with intent to completely remove or debulk the lesion prior to sample collection [examples include snare polypectomy, endoscopic mucosal resection (EMR), endoscopic submucosal dissection (ESD), surgical resection, trans anal excision]
  • Patient has prior diagnosis of non-lynch hereditary colon cancer syndrome [familial adenomatous polyposis (FAP), MUTYH-associated polyposis (MAP), Peutz-Jeghers syndrome (PJS), juvenile polyposis syndrome (JPS), PTEN, POL]
  • ADDITIONAL STOOL EXCLUSIONS:
  • Bowel prep < 7 days prior to stool collection
  • Oral or rectal contrast given within 7 days prior to stool collection
  • Removal of more than 50% of colon or presence of ileostomy
  • Enteral feeds or total parenteral nutrition (TPN)
  • Diagnosis of inflammatory bowel disease

Locations

  • University of California San Francisco accepting new patients
    San Francisco California 94115 United States
  • Mayo Clinic in Arizona accepting new patients
    Scottsdale Arizona 85259 United States

Lead Scientist at University of California Health

  • Aparajita Singh,, MD (ucsf)
    Dr Singh is a board certified gastroenterologist with special interest in colon cancer prevention, high quality colonoscopy. Her other interests include patients with high risk for colon cancer with Lynch Syndrome, FAP and management of patients with a family history of colorectal cancers.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Mayo Clinic
ID
NCT05410977
Study Type
Observational
Participants
Expecting 750 study participants
Last Updated