Recruiting

Observational Study

Sponsor:

Weill Medical College of Cornell University

Code:

NCT06096688

Conditions

Colorectal Cancer

Endometrial Cancer

Hereditary Cancer Syndromes

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Study Details

Brief summary:

The primary aim of this study is to collect and store data, tissue, and personal and family histories from patients being screened for colorectal cancer and/or endometrial cancer at NYPH and WCM for routine clinical care and to make these available for future use for molecular and mechanistic studies.

Conditions

Colorectal Cancer

Endometrial Cancer

Hereditary Cancer Syndromes

Study ID

NCT06096688

Start date

May 29, 2019

Status verified date

Jul, 2026

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

The following eligibility criteria must be met as follows:

1. Age ≥ 18 years old.
2. One of the following must be met:

1. Diagnosis of a Hereditary Cancer Syndrome by positive genetic testing and/or clinical criteria to undergo an endoscopy procedure (esophagoduodenoscopy and/or colonoscopy/flexible sigmoidoscopy), or endometrial screening procedure (transvaginal ultrasound and/or hysteroscopy and/or endometrial biopsy), OR
2. Individuals coming to Weill-Cornell Medicine/NYPH to undergo an endoscopy procedure, transvaginal ultrasound, or hysteroscopy for average-risk (population-based) recommendation OR
3. Individuals diagnosed with colorectal cancer or endometrial cancer coming to Weill- Cornell Medicine/NYPH for surgical treatment OR
4. Individuals coming to Weill-Cornell Medicine/NYPH for care such as, but not limited to, diagnostic testing, clinic and/or treatment visit.
3. Willingness and ability to sign informed consent.
4. Ability to read/understand English, Spanish, and/or simplified Chinese.

Study Design

Enrollment

1120 participants

Anticipated

Interventions and Outcome Measures

Arms

FAP without treatment with NSAIDs

Patients with the Hereditary Cancer Syndrome known as Familial Adenomatous Polyposis (FAP) undergoing upper or lower endoscopy/surgery without treatment with NSAIDs

FAP on treatment with NSAIDs

Patients with the Hereditary Cancer Syndrome known as Familial Adenomatous Polyposis (FAP) undergoing upper or lower endoscopy/surgery on treatment with NSAIDs

HNPCC without treatment with NSAIDs

Patients with the Hereditary Cancer Syndrome known as Hereditary Non-Polyposis Colorectal Cancer (HNPCC) undergoing lower endoscopy/surgery without treatment with NSAIDs

HNPCC on treatment with NSAIDs

Patients with the Hereditary Cancer Syndrome known as Hereditary Non-Polyposis Colorectal Cancer (HNPCC) undergoing lower endoscopy/surgery on treatment with NSAIDs

Other Hereditary Colorectal Cancer Syndromes

Other Hereditary Colorectal Cancer Syndromes undergoing lower endoscopy/surgery

Average-risk population

Average-risk population undergoing lower endoscopy/surgery in the lower gastrointestinal tract.

Primary outcome measure

  • Novel mechanisms and genes inducing genetic predisposition to Hereditary Cancer Syndromes [ Time Frame: 7 years ]
  • New genes and proteins for targeted therapy in Hereditary Cancer Syndromes [ Time Frame: 7 years ]
  • Understanding and learning about the immune system's ability to recognize and kill tumor cells [ Time Frame: 7 years ]

Central Contacts and Locations

Central contacts

Julie M Blander, PhD

646-962-6741jub2031@med.cornell.edu

Melissa K Frey, MD, MS

646-697-6621mkf2002@med.cornell.edu

Locations

NYP/Weill Cornell Medicine

Recruiting

New York, New York, United States, 10065

Contacts

Julie M Blander, PhD

+1 646 962 6741jub2031@med.cornell.edu

Principal Investigator:

Julie M Blander, PhD

More Information

Sponsor

Weill Medical College of Cornell University

Last update posted

Aug 3, 2026

Last verified

Jul, 2026

Keywords

  • personal and family history
  • genomic/epigenetic
  • polyps
  • carcinomas
  • Hereditary Cancer Syndromes
  • mucosa
  • blood serum markers
  • chemoprevention
  • registry

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Weill Medical College of Cornell University on 2026-08-03.