Ohio Colorectal Cancer Prevention Initiative (OCCPI)

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2015 by Ohio State University Comprehensive Cancer Center
Sponsor:
Information provided by (Responsible Party):
Heather Hampel, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01850654
First received: May 3, 2013
Last updated: December 1, 2015
Last verified: December 2015
  Purpose

The purpose of the Ohio Colorectal Cancer Prevention Initiative (OCCPI) is to reduce morbidity and mortality due to colorectal cancer (CRC) in the state of Ohio. By identifying individuals at high-risk for CRC (genetically predisposed) and providing screening recommendations for cancer risk reduction, the OCCPI will understand how to increase length of life and quality of life for those diagnosed with CRC in Ohio, as well as to better prevent CRC in others in Ohio.

Participants will have free tumor screening for Lynch syndrome, and may be eligible for free genetic testing and free genetic counseling as part of this study.


Condition Intervention
Lynch Syndrome
Colorectal Cancer
Genetic: LS tumor screening
Genetic: Genetic testing
Behavioral: Genetic Counseling
Other: Biorepository
Behavioral: Questionnaire

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: Ohio Colorectal Cancer Prevention Initiative: Universal Screening for Lynch Syndrome

Resource links provided by NLM:


Further study details as provided by Ohio State University Comprehensive Cancer Center:

Primary Outcome Measures:
  • Determine the Incidence of Hereditary Cancer Syndromes among Newly Diagnosed Colorectal Cancer Patients [ Time Frame: 24 months (initial assessment) ] [ Designated as safety issue: No ]
    Through tumor testing for Lynch syndrome and follow-up genetic testing for all patients with abnormal tumor testing and select patients with normal tumor testing (those diagnosed under age 50 and those at 50 or over with a first degree relative with colorectal or endometrial cancer or synchronous or metachronous colon or endometrial cancer).


Estimated Enrollment: 5000
Study Start Date: December 2012
Estimated Study Completion Date: September 2018
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Probands
Participants with colorectal or endometrial cancer.
Genetic: LS tumor screening
All participants with CRC or EC will have LS tumor screening (MSI, IHC, methylation if applicable).
Other Names:
  • MSI
  • IHC
  • Methylation
Genetic: Genetic testing

Next-generation sequencing panel of several genes that increase the risk for hereditary cancers including the LS genes (MLH1, MSH2, MSH6, PMS2, EPCAM), polyposis genes (MUTYH, APC), and others.

The following study participants will have free genetic testing:

  • CRC and EC study participants with unmethylated MSI-high (MSI-H) tumors
  • CRC and EC study participants with microsatellite stable (MSS) or MSI-low (MSI-L) tumors who have abnormal IHC results (MLH1 and PMS2 are absent) and they do not have methylation of the MLH1 promoter
  • CRC study participants diagnosed with CRC <50 years with normal tumor studies, regardless of family history
  • CRC study participants diagnosed with CRC ≥ 50 years with normal tumor studies AND a FDR with CRC or EC OR synchronous or metachronous CRC or EC throughout their life.

At-risk relatives of the individuals found to have LS are eligible for free single site genetic testing.

Behavioral: Genetic Counseling

The participants found to have LS or another type of hereditary cancer will have free genetic counseling.

At-risk relatives of the individuals found to have LS are eligible for free genetic counseling.

Other: Biorepository
The biorepository is an optional part of the OCCPI. CRC and EC participants will contribute leftover tumor and blood samples, as well as a saliva sample. FDR of the CRC participants will contribute a saliva sample. The at-risk relatives of those found to have LS will contribute blood and saliva samples.
Behavioral: Questionnaire
First-degree relatives of the participants with CRC
The first-degree relatives of the CRC probands (participants with colorectal cancer).
Other: Biorepository
The biorepository is an optional part of the OCCPI. CRC and EC participants will contribute leftover tumor and blood samples, as well as a saliva sample. FDR of the CRC participants will contribute a saliva sample. The at-risk relatives of those found to have LS will contribute blood and saliva samples.
Behavioral: Questionnaire
At-risk relatives
The relatives of the participants found to have Lynch syndrome.
Genetic: Genetic testing

Next-generation sequencing panel of several genes that increase the risk for hereditary cancers including the LS genes (MLH1, MSH2, MSH6, PMS2, EPCAM), polyposis genes (MUTYH, APC), and others.

The following study participants will have free genetic testing:

  • CRC and EC study participants with unmethylated MSI-high (MSI-H) tumors
  • CRC and EC study participants with microsatellite stable (MSS) or MSI-low (MSI-L) tumors who have abnormal IHC results (MLH1 and PMS2 are absent) and they do not have methylation of the MLH1 promoter
  • CRC study participants diagnosed with CRC <50 years with normal tumor studies, regardless of family history
  • CRC study participants diagnosed with CRC ≥ 50 years with normal tumor studies AND a FDR with CRC or EC OR synchronous or metachronous CRC or EC throughout their life.

At-risk relatives of the individuals found to have LS are eligible for free single site genetic testing.

Behavioral: Genetic Counseling

The participants found to have LS or another type of hereditary cancer will have free genetic counseling.

At-risk relatives of the individuals found to have LS are eligible for free genetic counseling.

Other: Biorepository
The biorepository is an optional part of the OCCPI. CRC and EC participants will contribute leftover tumor and blood samples, as well as a saliva sample. FDR of the CRC participants will contribute a saliva sample. The at-risk relatives of those found to have LS will contribute blood and saliva samples.
Behavioral: Questionnaire

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Newly diagnosed with colorectal adenocarcinoma (all stages) and have a resection at any hospital in Ohio between 1/1/2013 and 12/31/2016.

    • For individuals who have neoadjuvant treatment and show a complete response at resection, the tumor screening will be attempted on their original biopsy (even if it occurred in 2012) as long as their resection occurred between 1/1/2013 and 12/31/2016.
    • Many individuals with stage IV CRC will not have a resection; therefore, the tumor screening will be attempted on their original colon biopsy as long as their primary diagnosis occurred between 1/1/2013 and 12/31/2016. If only metastatic CRC is available on a biopsy (liver or lymph node metastases), tumor screening will be attempted on the metastatic tissue.
  2. Newly diagnosed with endometrial cancer (any histology except sarcoma) and have a resection between 1/1/2013 and 12/31/2016 at OSU only.
  3. All at-risk relatives of the participants found to have LS.
  4. First-degree relatives (parents, siblings and adult children ≥ 25 years of age) of the CRC participants who do not have LS.

Exclusion Criteria:

  1. Prisoners.
  2. Individuals who are under the age of 18.
  3. Individuals must have a primary colorectal or endometrial cancer, not a recurrence of a previous colorectal or endometrial cancer.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01850654

Contacts
Contact: Rachel Pearlman, MS, LGC 614-293-5740 Rachel.Pearlman@osumc.edu
Contact: Heather Hampel, MS, LGC 614-293-7240 Heather.Hampel@osumc.edu

  Show 49 Study Locations
Sponsors and Collaborators
Ohio State University Comprehensive Cancer Center
Investigators
Principal Investigator: Heather Hampel, MS, LGC Ohio State University Comprehensive Cancer Center
  More Information

Additional Information:
Publications:
Responsible Party: Heather Hampel, Principal Investigator, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01850654     History of Changes
Other Study ID Numbers: OSU-12170 
Study First Received: May 3, 2013
Last Updated: December 1, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Ohio State University Comprehensive Cancer Center:
colorectal cancer
colon cancer
rectal cancer
endometrial cancer
Lynch syndrome
Ohio colon cancer study
OSU colon study

Additional relevant MeSH terms:
Colorectal Neoplasms
Colorectal Neoplasms, Hereditary Nonpolyposis
Colonic Diseases
DNA Repair-Deficiency Disorders
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Genetic Diseases, Inborn
Intestinal Diseases
Intestinal Neoplasms
Metabolic Diseases
Neoplasms
Neoplasms by Site
Neoplastic Syndromes, Hereditary
Rectal Diseases

ClinicalTrials.gov processed this record on May 23, 2016