Discovering New Targets for Colorectal and Endometrial Cancer Risk Reduction

NCT06096688 | Recruiting

• 2 other identifiers: 1803019093U01CA233056
• Study Type: observational
• Target: 1,120
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Novel mechanisms and genes inducing genetic predisposition to Hereditary Cancer Syndromes

  Discover novel mechanisms in intestinal carcinogenesis and genes inducing genetic predisposition to Hereditary Cancer Syndromes.

  7 years

• New genes and proteins for targeted therapy in Hereditary Cancer Syndromes

  Identify new genes and proteins that are amenable to targeted therapy and precision prevention drug intervention and biomarker development in Hereditary Cancer Syndromes.

  7 years

• Understanding and learning about the immune system's ability to recognize and kill tumor cells

  To facilitate understanding and learning about ways of how the immune system can be used to recognize and kill tumor cells that carry mutations.

  7 years

Study Arms (6)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

New York Presbyterian Hospital (NYPH) and Weill Cornell Medicine (WCM) Gastroenterology and Gynecologic Oncology Patients

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

NYP/Weill Cornell Medicine

New York, New York, 10065, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

BLOOD COLLECTION. Collection of 3-5 tubes of up to 10 ml each will be performed during standard of care blood draws. POLYP/TUMOR COLLECTION DURING PROCEDURE. Removal of polyps and/or tumor tissue will be performed according to standard clinical practices during standard clinical care procedures. NORMAL MUCOSA/TISSUE COLLECTION DURING PROCEDURE. Removal of normal mucosa will be performed according to standard clinical practices. INCOMPLETELY REMOVED POLYP/TUMOR SAMPLES. Lesions that are not or cannot be completely removed will undergo standard biopsy prior to the acquisition of research biopsies. RETROSPECTIVELY COLLECTED SAMPLES. The research team member will coordinate with the pathology team or research laboratory personnel to obtain the tissue and/or samples.

MeSH Terms

Conditions

Colorectal Neoplasms; Endometrial Neoplasms; Neoplastic Syndromes, Hereditary; Polyps; Carcinoma

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Steven M Lipkin, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Steven M Lipkin, MD, PhD

CONTACT

212-746-4014; stl2012@med.cornell.edu

Melissa K Frey, MD, MS

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2023
• First Posted: October 24, 2023
• Study Start: May 29, 2019
• Primary Completion (Estimated): May 29, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 4, 2025

Record last verified: 2025-08

Locations

US (1)