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Colorectal CancerNCT06096688

Discovering New Targets for Colorectal and Endometrial Cancer Risk Reduction

An observational study of Colorectal Cancer and Endometrial Cancer, run by Weill Medical College of Cornell University at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
How many people
1,120 participants
Where
1 siteUnited States
Study dates
29 May 2019to 30 Jun 2027
How long will I take part?
1 Year
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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:
  3. 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
  4. Individuals coming to Weill-Cornell Medicine/NYPH to undergo an endoscopy procedure, transvaginal ultrasound, or hysteroscopy for average-risk (population-based) recommendation OR
  5. Individuals diagnosed with colorectal cancer or endometrial cancer coming to Weill- Cornell Medicine/NYPH for surgical treatment OR
  6. Individuals coming to Weill-Cornell Medicine/NYPH for care such as, but not limited to, diagnostic testing, clinic and/or treatment visit.
  7. Willingness and ability to sign informed consent.
  8. Ability to read/understand English, Spanish, and/or simplified Chinese.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Julie M Blander, PhD contact

646-962-6741

jub2031@med.cornell.edu

Melissa K Frey, MD, MS contact

646-697-6621

mkf2002@med.cornell.edu

United States1 site, 1 recruiting
  • NYP/Weill Cornell Medicine

    New York, New York, 10065

    Julie M Blander, PhD, +1 646 962 6741, jub2031@med.cornell.edu

    Julie M Blander, PhD

    Recruiting

Other trials in United States

About this study

Official title: Discovering New Targets for Hereditary and Sporadic Colorectal and Endometrial Cancer Risk Reduction

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.

Read the detailed description

Colorectal cancer (CRC) and endometrial cancer (EC) have a highly heritable component. Approximately 25% of CRC or EC patients have another first or second degree relative who are also affected by CRC or EC, and there are at least 32 known high penetrance CRC/EC germline predisposition genes. The overarching goal of this protocol is to (a) facilitate the discoveries of novel mechanisms in intestinal carcinogenesis and genes inducing genetic predisposition, (b) to help identify new genes and proteins that are amenable to targeted therapy and precision prevention drug intervention and biomarker development in Hereditary Cancer Syndromes, (c) to facilitate understanding and learning about ways of how the immune system can be used to recognize and kill tumor cells that carry mutations. To accomplish these goals, we plan to pursue the following aims:

  1. To collect tissue and blood samples for storage, so they can be made available to future research studies and scientist aiming to learn more about the underlying causes of gastrointestinal cancers and endometrial cancers, both in patients with hereditary cancer syndromes and in the general population,
  2. To develop organoids from adenocarcinomas, polyps, and normal intestinal mucosa samples in patients with Hereditary Cancer Syndromes and a sporadic cohort as a comparator and control. These organoids will be derived from tissue biopsies of different parts of the intestinal tract, other GI organs, and endometrium in order to perform assessment of drug sensitivity and molecular biology experiments to understand the biology and carcinogenesis of the intestine.

To accomplish these goals, we will obtain normal mucosa, polyp tissue and carcinoma (tumor tissue) arising in the upper gastrointestinal tract (mainly the duodenum, but also other potential locations such as the esophagus, GE junction, stomach, and small bowel), lower gastrointestinal tract (mainly the colorectum), paired normal mucosa samples, endometrial tissue, and blood and as a source of genomic DNA, RNA, and protein.

The biospecimen samples will be collected in the context of standard of care (SOC) endoscopic procedure(s) and/or from pathologic specimens obtained during gastrointestinal (GI) endoscopy procedures and surgery performed at Weill Cornell or New York Presbyterian Hospital, including diagnostic testing, clinic and/or treatment visit and/or from residual blood. These tissue samples and blood samples were collected in the context of routine care and procedures performed at Weill-Cornell and NYPH. Biospecimen samples will also be collected in the context of SOC transvaginal ultrasound, hysteroscopy and endometrium biopsy performed at Weill Cornell or New York Presbyterian Hospital, including diagnostic testing, clinic and/or treatment visit.

Blood samples will be collected at the time blood is taken for clinical care. We will register, collect, process and store frozen blood, frozen normal and diseased tissue and FFPE (formalin fixed paraffin embedded) specimens.

This will be an invaluable annotated hereditary CRC/EC registry and tissue repository that will be available to the Weill Cornell Community upon appropriate approval. Subjects that provide informed consent will agree to collection and storage of clinical data. For the purposes of this project, clinical data includes all data collected for standard clinical purposes (e.g., demographics, medical issues, prognostic data, treatment data, outcomes).

Keywords
personal and family history, genomic/epigenetic, polyps, carcinomas, Hereditary Cancer Syndromes, mucosa, blood serum markers, chemoprevention, registry
Medical subject headings
Colorectal Neoplasms, Endometrial Neoplasms, Neoplastic Syndromes, Hereditary, Polyps, Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06096688
Study groupRoleWhat they receive
FAP without treatment with NSAIDsPatients 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 NSAIDsPatients 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 NSAIDsPatients 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 NSAIDsPatients 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 SyndromesOther Hereditary Colorectal Cancer Syndromes undergoing lower endoscopy/surgery
Average-risk populationAverage-risk population undergoing lower endoscopy/surgery in the lower gastrointestinal tract.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 7 years

  2. 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.

    Measured: 7 years

  3. 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.

    Measured: 7 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Oct 2023
  2. Study start29 May 2019
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion30 Jun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,120 participants (estimated)
Target duration
1 Year
IDs, dates and publications
ClinicalTrials.gov ID
NCT06096688
Sponsor's protocol ID
1803019093
Other IDs
U01CA233056
Status last verified
Jul 2026
First submitted
17 Oct 2023
Last updated
3 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Colorectal Cancer and Endometrial Cancer, run by Weill Medical College of Cornell University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Julie M Blander, PhD (646-962-6741, jub2031@med.cornell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Novel mechanisms and genes inducing genetic predisposition to Hereditary Cancer Syndromes (time frame: 7 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.

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