Neoplasms

Digestive System Diseases

Diseases and Abnormalities at or Before Birth

All Conditions

Symptoms and General Pathology

Nutritional and Metabolic Diseases

Rare Diseases

Adenomatous Polyposis Coli

Syndrome

Colorectal Neoplasms

Colorectal Neoplasms, Hereditary Nonpolyposis

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Neoplastic Syndromes, Hereditary

Genetic Diseases, Inborn

DNA Repair-Deficiency Disorders

Metabolic Diseases

Polyps

Adenomatous Polyps

Adenoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Intestinal Polyposis

Familial Adenomatous Polyposis

MYH-associated Polyposis

All Drugs and Chemicals

Herbal and Botanical

Antibodies

Immunoglobulins

Cola

Clinical diagnosis of familial adenomatous polyposis (FAP).

The patients of the disease and control groups participating in the study are followed up clinically and with blood draws at least every 6 months for the duration of 2 years. These follow-ups might be more frequent, if warranted by the clinical course of the individual disease in the participating patients. Blood draws in FAP patients should always be accompanied by blood draws in their family member controls.

If colectomy is performed in a patient of any disease group within the study participation period, additional blood draws will occur prior to any surgical bowel preparation and within a 28-day window after surgery.

Clinical diagnosis of Lynch Syndrome, also known as HNPCC.

The patients of the disease and control groups participating in the study are followed up clinically and with blood draws at least every 6 months for the duration of 2 years. These follow-ups might be more frequent, if warranted by the clinical course of the individual disease in the participating patients.

If colectomy is performed in a patient of any disease group within the study participation period, additional blood draws will occur prior to any surgical bowel preparation and within a 28-day window after surgery.

Clinical diagnosis of MYH-associated polyposis and presence of more than 20 colon polyps.

The patients of the disease and control groups participating in the study are followed up clinically and with blood draws at least every 6 months for the duration of 2 years. The follow-ups might be more frequent, if warranted by the clinical course of the individual disease in the participating patients.

If colectomy is performed in a patient of any disease group within the study participation period, additional blood draws will occur prior to any surgical bowel preparation and within a 28-day window after surgery.

Genetically related family member of enrolled FAP patient.

Controls, i.e. relatives of patients: Willingness to give blood at each routine follow-up as advised for the diseased relative.

The patients of the control group participating in the study are followed up clinically and with blood draws at least every 6 months for the duration of 2 years. These follow-ups might be more frequent, if warranted by the clinical course of the individual disease in the participating FAP patients.

If colectomy is performed in a FAP patient of any disease group within the study participation period, additional blood draws will occur prior to any surgical bowel preparation and within a 28-day window after surgery.

Blood draws in FAP patients should always be accompanied by blood draws in their family member controls.

Plasma specimens will be collected and processed according to the Instructions for Use of the Epi proColon investigational device.

For circulating colonic epithelial cell analysis, at least one ml whole blood will be required for analysis. Samples will be analyzed for circulating epithelial cells using the geometrically enhanced immunocapture device (GEDI; Gleghorn et al., 2009). Circulating epithelial cells will be captured using EpCAM antibodies and quantified by immunofluorescence microscopy as defined as cells that are DAPI+, CK+, CD45-. Captured cells will be fixed and stored at -20˚C.

Epi proColon Testing

Bryson Katona, MD

This is an observational, case-control study evaluating the quantitative level of Septin9 in plasma pre- and post-colectomy in hereditary colorectal cancer (CRC) syndrome patients (Familial Adenomatous Polyposis (FAP), Lynch syndrome (also known as HNPCC), and Multiple Adenomatous Polyposis (MAP, also known as MYK/MYH) cases) and genetically related FAP-family members as controls and references.

Blood samples will be used as per the study protocol. Consented subjects will provide at least 10 ml but not more than 20 ml (for repeating testing) of blood at each time point for Epi proColon testing. An additional volume of up to 10 ml anticoagulated blood will be drawn for circulating colonic epithelial cell analysis at each time point. Blood samples will be stored and will only be used in future research with the express written permission of study subjects. Subjects may withdraw consent from the study or for future use of blood samples at any time.

Preliminary Evaluation of Septin9 in Patients With Hereditary Colon Cancer Syndromes

The primary endpoint of the study is the completion of Septin9 monitoring in the individual patient disease groups (or family controls) over a period of two years or in case of colectomy within 28 days after colectomy. The endpoint is defined as the documented receipt of blood draws at least every six months on the scheduled healthcare visit at the institute after enrollment over the two years participation period. If any patient needs to undergo colectomy within the two years of study participation, the endpoint is defined as documented receipt of both blood draws occured prior to any surgical bowel preparation and 28 days at the latest after surgery.

The secondary endpoints of the study are the documented results of the circulating colonic epithelial cell numbers for each blood draw performed.

The primary objective of the study is the observational analysis of quantitative Septin9 plasma levels over time in hereditary CRC syndrome patients pre- and post-colectomy.

• Correlation of quantitative Septin9 plasma levels with the approx. number of polyps

• Correlation of circulating colonic epithelial cell number pre- and post-colectomy

• Correlation of circulating colonic epithelial cell number with Septin9 levels

Epigenomics, Inc

University of Pennsylvania

Patients will receive a letter noting that they are not up-to-date on screening and encouraging them to contact a study number if they choose to screen with colonoscopy or FIT. Patients who call will speak to a research assistant who is trained in patient navigation and can facilitate referrals for colonoscopy or FIT. Patients will receive a follow-up telephone call that reiterates information in the letter.

Patients will also be asked to complete a questionnaire about their beliefs and attitudes regarding CRC screening. The questionnaire will be mailed with the invitation letter and will also be administered over the telephone by the research assistant.

Patients will receive a letter noting that they are not up-to-date on screening and encouraging them to contact a study number if they choose to screen with colonoscopy or FIT. Letters will also include an option to participate in the blood test, with instructions to call the study number to schedule the blood draw. This option will not appear in the letters sent to the control group. Patients will also receive a follow-up telephone call and a questionnaire.

Participants who choose to the blood test (Septin9) will undergo phlebotomy. The blood sample will be run by an off-site commercial laboratory. The study team will notify patients and their primary care physicians of blood test results and will facilitate a colonoscopy referral for those with positive tests.

Septin9 is a FDA-approved blood test for colorectal cancer screening

Septin9

Objectives:

Colonoscopy and stool-based testing are the two predominant colorectal cancer (CRC) screening tests used in the US, and both reduce colorectal cancer mortality. However, only 62% of Americans are up to date with screening, partly because many individuals find these two tests inconvenient or unacceptable for a variety of reasons. There is an unmet need for a non-invasive test that does not require bowel preparation or handling stool, and the Septin9 DNA blood test may be an alternative for those individuals who would otherwise remain unscreened.

Aims:

Aim 1: To measure screening uptake with a blood test in screen-resistant patients who have declined both colonoscopy and fecal immunochemical testing (FIT) at the Manhattan VA Medical Center

* Sub-Aim 1a: To assess the proportion of those with a positive blood-based screening test who undergo diagnostic colonoscopy
* Sub-Aim 1b: To describe the endoscopic findings on diagnostic colonoscopy

Aim 2: To survey screen-resistant patients to understand their beliefs and attitudes about colorectal cancer screening and testing options

We hypothesize that a substantial proportion of patients who have refused colonoscopy and FIT will accept the blood test. We hypothesize this will be driven by the convenience of the blood test.

Methods:

This will be randomized controlled trial of individuals who have refused colonoscopy and FIT within past 6 months. Eligible patients will be randomized 1:1 to the intervention or control group. Both groups will be invited to participate in navigated colonoscopy or FIT by letter and telephone call. The intervention group will also be invited to participate in the blood test if they refuse colonoscopy and FIT. We will enroll 180 participants in each group (total n=360).

The proposed study is a randomized controlled trial that will 1) assess the uptake of a CRC screening blood test among patients who have declined both colonoscopy and FIT in the previous 6 months, including diagnostic evaluation of positive results and 2) survey patients about their beliefs and attitudes regarding CRC screening and testing options. All participants will be primary care patients at the Manhattan VA Medical Center. Based on a recent internal audit, there were 1502 patients who had at least one primary care visit from August 2016 through August 2017 and were not up to date with CRC screening. Up-to-date CRC screening is defined as either 1) a colonoscopy within the past 10 years or 2) FIT within the past year. We will perform an updated CRC screening audit at the beginning of the study to obtain the entire pool of eligible patients who are not up to date with screening. Eligible patients will then be randomized 1:1 to either an intervention group or a control group. All patients will receive a letter noting that they are not up-to-date on screening and encouraging them to contact a study number if they choose to screen with colonoscopy or FIT. Patients who call will speak to a research assistant who is trained in patient navigation and can facilitate referrals for colonoscopy or FIT. Following the sequential testing approach, letters addressed to the intervention group will also include an option to participate in the blood test, with instructions to call the study number to schedule the blood draw. In addition to the letter, both groups will also receive a follow-up telephone call that reiterates information in the letter. The research assistant will make and receive all calls using a standard script. All patients will also be asked to complete a survey about their beliefs and attitudes regarding CRC screening. The survey will be mailed with the invitation letter and will also be administered over the telephone by the research assistant. The study team will notify patients and their primary care physicians of blood test results and will facilitate a colonoscopy referral for those with positive tests. Primary care physicians will not be asked to notify the patients or make the colonoscopy referral because most will not have adequate knowledge of the Septin9 test to provide appropriate patient education.

Participants who are randomized to the blood test arm will undergo phlebotomy, which will be performed by the study research assistant. The blood sample will be temporarily stored on-site and then transported to an off-site commercial laboratory (Lenco Diagnostic Laboratory, Brooklyn, NY) to run the assay.

Clinical outcomes for both the intervention and control group participants will be measured as a secondary outcome. This includes timing and result of a screening colonoscopy or FIT for individuals in the controls group as well as diagnostic colonoscopy for participants who had a positive blood test.

Eligible patients will be randomized 1:1 to the intervention or control group

Assessing the Effect of a Blood-based Colorectal Cancer Screening Test on Screening Adherence and Colonoscopy Completion

Assessing the Effect of Offering a Blood-based Colorectal Cancer Screening Test on Screening Adherence and Colonoscopy Completion in Patients Who Have Refused Colonoscopy and FIT

Percentage of participants who undergo screening in the intervention group vs. control group, measured 6 months after the initial letter was sent

Complete screening in both groups, which is defined as completion of the entire screening strategy. For colonoscopy, this requires cecal intubation and an adequate bowel preparation. For individuals who took Septin9 and FIT, positive results must be followed by a colonoscopy with cecal intubation and adequate bowel preparation.

Among individuals in the intervention group who had a positive blood test, proportion who completed a follow-up colonoscopy within 6 months.

Percentage of both groups who answered that they would be willing to take a blood test for colorectal cancer screening

The most commonly cited advantages of a blood test compared to colonoscopy and stool test in both groups

The most commonly cited reasons for not taking the blood test in the intervention group.

Peter S. Liang, MD MPH

Staff Physician

Control

Patients will receive a letter noting that they are not up-to-date on screening and encouraging them to contact a study number if they choose to screen with colonoscopy or FIT. Letters will also include an option to participate in the blood test, with instructions to call the study number to schedule the blood draw. This option will not appear in the letters sent to the control group. Patients will also receive a follow-up telephone call and a questionnaire.

Participants who choose to the blood test (Septin9) will undergo phlebotomy. The blood sample will be run by an off-site commercial laboratory. The study team will notify patients and their primary care physicians of blood test results and will facilitate a colonoscopy referral for those with positive tests.

Septin9: Septin9 is a FDA-approved blood test for colorectal cancer screening

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

The analysis population is excluding Hispanics in this total, as it was already recorded in a different section. This is why the total is less than the original total.

Race (NIH/OMB)

United States

Region of Enrollment

Individuals who are eligible for colorectal cancer screening and have previously declined colonoscopy and FIT.

Anika Zaman

Percentage of Participants Who Undergo Screening Within 6 Months of Outreach

Percentage of Participants Completing Screening Strategy

The overall number of participants analyzed corresponds to the number of participants with a positive FIT.

Percentage of Participants With Colonoscopy Follow-up in Intervention Group

The survey was sent out to both control and intervention patients and all surveys contained the same questions. It investigated patients' perspectives on colonoscopy and FIT in order to understand barriers to screening. The survey also assessed whether these patients would be amenable to a blood-based CRC screening test.

Surveys/Questionnaires Mailed

The same survey was sent to all participants. The planned analysis was to include all participants who returned the survey, rather than stratified by arm.

Self-reported Willingness to Take Blood Test for Colorectal Cancer Screening on Questionnaire

Patients are willing to go through a blood test for colorectal cancer screening due to the convenience of taking a blood test.

Convenience

Patients are willing to take blood tests for colorectal cancer screening due to a lack of extra preparation for a blood test.

No Special Preperation

Patients are willing to do a blood test for colorectal cancer screening because they feel accustomed to blood draw tests.

Accustomed to Blood Tests

Self-reported Most Common Advantages of Blood Test on Questionnaire

Patients who declined blood draws for colorectal cancer do not believe it is as accurate as the FIT test.

Not as Accurate as FIT

Patients who declined blood draws for colorectal cancer screening state they are uncomfortable with blood draws.

Uncomfortable With Blood Draws

The overall number of participants who indicated that they would refuse a blood test on the questionnaire.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Preliminary Evaluation of Septin9 in Patients With Hereditary Colon Cancer Syndromes	NCT02198092	Familial Adenom... Map Syndrome Lynch Syndrome Hnpcc Colorectal Canc...	Epi proColon Te...	18 Years -	University of Pennsylvania
Assessing the Effect of a Blood-based Colorectal Cancer Screening Test on Screening Adherence and Colonoscopy Completion	NCT03598166	Colorectal Canc...	Septin9	50 Years - 75 Years	VA New York Harbor Healthcare System

Spots Global Cancer Trial Database for septin9

Every month we try and update this database with for septin9 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for septin9

Every month we try and update this database with for septin9 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for septin9 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.