Neoplasms

Digestive System Diseases

All Conditions

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Subject aged 45-49 with average risk for development of CRC.

Stool samples will be collected by the subject for the mt-sDNA screening test.

mt-sDNA screening test

Subjects will undergo a screening colonoscopy.

Colonoscopy

Thomas Imperiale, MD

The primary objective is to confirm the specificity of a multi-target stool DNA test (mt-sDNA), Cologuard, in an average risk population, ages 45-49.

Subjects aged 45-49 at average risk for development of CRC will be enrolled. Subjects will complete the mt-sDNA screening test (Cologuard) followed by completion of a screening colonoscopy. The results of the mt-sDNA screening test (Cologuard) will not be provided to investigators for clinical management of study subjects. Personnel performing the colonoscopy and producing the resulting report and personnel performing histopathological review of tissue (if applicable) will remain blinded to the results of the mt-sDNA screening test (Cologuard) result.

Residual stool samples may be used to develop and evaluate the performance of biomarker assays to detect cancers. Sample may be stored for up to 20 years. These stool samples will be de-identified.

An Evaluation of a Multi-target Stool DNA (Mt-sDNA) Test, Cologuard, for CRC Screening in Individuals Aged 45-49 and at Average Risk for Development of Colorectal Cancer: Act Now

Individual participant data that underlie the results reported in publications of the study will be shared after de-identification. This may include text, tables, figures, and appendices. The study protocol, statistical analysis plan, informed consent form, and clinical study report will also be shared. Data will be shared with researchers who provide a methodologically sound proposal to achieve the aims outlined in the approved proposal.

An optical colonoscopic procedure is the reference method. Lesions will be confirmed as malignant by histopathologic examination. Results were generated with the use of a logistic-regression algorithm, with values of 183 or more considered to be positive. Tests were processed independently of colonoscopic findings. The test functions as a screening tool by generating a score, based on the detection of hemoglobin and multiple DNA methylation and mutational markers, together with an assessment of the total amount of human DNA in each sample. Specificity =100\*(multi-target stool DNA test negative/negative colonoscopy)

Exact Sciences Corporation

Only device related adverse events were collected.

Subjects were men and women 45-49 years of age, inclusive, who were at average risk of developing colorectal cancer. We compared results of a noninvasive, multi-target stool DNA test to colonoscopy. Histopathology was performed on any biopsy or excised lesions.

Average Risk Patients

Age, Continuous

Sex: Female, Male

Ethnicity: Hispanic or Latino

Ethnicity: Not Hispanic or Latino

Race: White

Race: Black or African American

Race: Asian

Race: American Indian or Alaska Native

Race: Native Hawaiian or Other Pacific Islander

Race: Other

Race/Ethnicity, Customized

United States

Region of Enrollment

BMI: mean (SD)

Never Smoked

Former Smoker

Current Smoker

Cigarette Smoking History n(%)

All evaluable participants except for participants who had mt-sDNA or colonoscopy excluded.

Subjects with colonoscopic non-advanced adenoma findings were included in the specificity analysis as disease status negative. The colonoscopically 'negative' population included subjects with no findings on colonoscopy and have a higher specificity.

Alexandra Massoud, Sr. Director of Clinical Affairs

Subjects were men and women 45-49 years of age, inclusive, who were at average risk of developing colorectal cancer. We compared results of a noninvasive, multitarget stool DNA test to colonoscopy. Histopathology was performed on any biopsy or excised lesions.

Multi-target DNA Test Results

All completed participants that had a negative colonoscopy.

Specificity of the Multi-target Stool DNA Test in Average Risk Population, Ages 45-49

Overall Study

Adenoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Anti-Inflammatory Agents

Antirheumatic Agents

Analgesics

All Drugs and Chemicals

Chrysarobin

A diagnostic device measuring syndecan 2(SDC2) methylation status in stool DNA to detect colorectal cancer

Stool-based SDC2 DNA methylation test

A diagnostic device using immunoturbidimetric methods to measure fecal hemoglobin concentration

quantitative Fecal immunochemical test

Zhaoshen Li, MD

to determine screening value of stool-based SDC2 DNA methylation test for advanced colorectal neoplasia in the asymptomatic Chinese community population.

In China, colorectal cancer (CRC) remains to be the leading cancer of the digestive system. According to nationwide cancer statistics using population-based cancer registry data in China, age-standardized incidence rate of CRC and age-standardized mortality rate increased significantly from 2000 to 2015. It induces a substantial financial burden in terms of healthcare utilization and quality-adjusted life years (QALY) lost. Fecal Occult Blood Tests (FOBT) and colonoscopy have been proposed as the main primary screening modalities for asymptomatic subjects by international guidelines and Asia Pacific Consensus Statements. Nevertheless, shortage and uneven distribution of colonoscopy resources combined with huge population base consisted of the current situation in China. Previous population-based CRC screening programs usually employed questionnaires and/or FOBT to assess high-risk groups and recommended colonoscopy. This algorithm faced difficulties such as complex traditional questionnaires, low colonoscopy adherence, and a high false-positive rate. When the Coronavirus disease 2019 pandemic further limited the implementation of colonoscopy, the contradictions developed more acute.

A Hong Kong group had designed and validated a colorectal cancer risk scoring system based on age, gender, smoking history, and family history through the results of screening in 11 Asia-Pacific cities. The Asia-Pacific Colorectal Screening (APCS) score was more concise and divided the population into three categories: low risk, intermediate risk, and high risk. Compared with the low-risk population, the probability of advanced colorectal neoplasia in intermediate-risk and high-risk population increased by 2.6 times and 4.3 times respectively. Because of simplicity and efficiency, it was recommended by Asia-Pacific screening guidelines and several guidelines in China. Another APCS related multi-center study indicated that by selecting high-risk subjects and low/average-risk subjects with a positive fecal immunochemical test (FIT) for colonoscopy, the colonoscopy workload could be reduced by 50% compared with the strategy of primary colonoscopy in those same subjects. All these experiences deserved to be drawn on during the post-pandemic era.

The recent decade has witnessed a rapid development of non-invasive biomarkers to detect CRC. Stool DNA(sDNA) Testing is a novel screening test for CRC, using molecular techniques to identify CRC-relevant biomarkers in stool. One of its toolkits, Multitarget Stool DNA Testing (FIT-DNA), was first approved by the FDA in 2014 for its application in clinical practice, which has been widely promoted in the United States. Subsequently, it was endorsed by multiple societies as one of the recommended screening tests.

Recently, a stool test of methylated Syndecan-2(SDC2) has been developed as a fecal-DNA product targeted to improve the diagnostic accuracy of CRC screening. A meta-analysis of previous clinical studies reporting the accuracy of stool DNA methylation tests in detecting CRC included 46 studies totaling 16,149 patients. The most accurate single gene was found to be SDC2 with a pooled sensitivity of 83.1% (72.6%, 90.2%) and a specificity of 91.2% (88.6%, 93.2%). A recent study involving 1,110 subjects from 2017 to 2018 by three Chinese tertiary hospitals assessed the performance of the SDC2 sDNA test. The sensitivity of the SDC2 sDNA test was 301/359 (83.8%) for CRC, 16/38 (42.1%) for advanced adenomas, and 134/154 (87.0%) for early-stage CRC (stage I-II), while maintaining a specificity of 699/713 (98.0%). Nevertheless, there were limitations in the design of these original studies. For instance, most involved small, hospital-based CRC cases and controls that might not fill the knowledge gap between population screening. Additional clinical trials are required to further validate its diagnostic accuracy in other populations, especially community-setting.

Potential participates would be recruited via community public communication. The subjects would be asked to fill in a concise questionnaire obtained through a public WeChat account after informed consent. Basic information would be acquired while APCS score and correspondent risk categories would be calculated automatically. After sampling education, stool collection devices of sDNA and quantitative fecal immunochemical test (qFIT) would be distributed to all subjects. Two samples of stool from single defecation would be requested to put into the two collection devices according to instructions respectively by the subjects themselves at home.

Efforts would be made by the public WeChat account and the community staff to urge samples recover from subjects as quickly as possible (prefer within 24h after defecation). Community staff would deliver the samples qualified in the initial evaluation to the standardized laboratory for testing as quickly as possible. If APCS be evaluated high-risk or any of qFIT or sDNA tests positive, the risk of the subject would be considered increased. Colonoscopy would be strongly recommended, and priority and rapid arrangement would be made in the corresponding center. For subjects with low/intermediate-risk APCS and negative qFIT and sDNA, the project team also encourages the subjects to accept colonoscopy on the basis of a clear understanding of benefits and risks. We would help to arrange colonoscopy as early as possible.

All colonoscopy examinations will be performed by experienced endoscopists while monitoring quality of colonoscopy (bowel preparation, cecal intubation rate and withdrawal time). Full-time recording personnel would be arranged to follow up and record the relevant information of colonoscopy. For the subjects diagnosed with colorectal cancer, the postoperative diagnosis and tumor-node-metastasis (TNM) staging of the subjects would be retrieved.

A Stool DNA Test for Detection of Advanced Colorectal Neoplasia in Asymptomatic Chinese Community Population

Detection of Advanced Colorectal Neoplasia for Stool DNA in Asymptomatic Chinese Population : A Multi-central Community-based Screening Study

Advanced colorectal neoplasia is defined as a colorectal adenoma or sessile serrated lesion ≥10 mm, adenoma or sessile serrated lesion with tubulovillous or villous histology, adenoma with high-grade dysplasia, traditional serrated adenoma, or presence of colorectal cancer.

The compliance rate of colonoscopy was calculated as the number of recieving colonoscopy divdied the number of accomplishing primary evaluation of APCS, stool DNA or FIT.

Lesions will be confirmed as malignant by histopathologic examination.

Advanced colorectal neoplasia is defined as a colorectal adenoma or sessile serrated lesion, traditional serrated adenoma, hyperplastic polyp ≥10 mm, or colorectal cancer.

Lesions will be confirmed as malignant or precancerous by histopathologic examination.

High-risk subgroup: APCS calculated high-risk or qFIT positive. A diagnostic colonoscopy procedure is the reference method. Lesions will be confirmed as malignant or precancerous by histopathologic examination.

Low-risk subgroup: APCS calculated low or medium risk, and qFIT negative. A diagnostic colonoscopy procedure is the reference method. Lesions will be confirmed as malignant or precancerous by histopathologic examination.

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Gongli Hospital of Shanghai Pudong New Area

Shanghai Songjiang District Central Hospital

Shanghai Jing'an District Central Hospital

Shanghai Yangpu District Central Hospital

People's Hospital of Qingyuan

Guangdong Provincial Hospital of Traditional Chinese Medicine

900 Hospital of the Joint Logistics Team

First Affiliated Hospital of Suzhou Medical College

Affiliated Hospital of Jiangnan University

Traditional Chinese Medicine Hosipital of Kunshan

Ankang Central Hospital

Shandong Cancer Hospital and Institute

Ningjin County Hospital

Changhai Hospital

MD,Director, Head of Department of Gastroenterology and Digestive Endoscopy Center, Principal Investigator, Clinical Professor

A diagnosis of CRC confirmed with a tissue biopsy or a colorectal lesion at least 1 cm in size suspicious for adenoma (including sessile serrated adenoma) or CRC on a pre-enrollment colonoscopy.

Amber Cheng

Omo Imaku

John Kasher

Alejandra Carpio

Gregory Wiener

Cecile Guttermuth

Salam Zakko

Grace Cortezzo

Xavier Llor, Md

Christiana Ansong

Atsushi Sakuraba

Ranjit Singh

Charles Berkelhammer, MD

Kathy Robinson

Venkateswara Poola

Beverly Carroll

Humberto I Aguilar, MD

Kathy Hughes

Leslie Bank, MD

Beth Martinotti, CCRC

Jason Wilson, MD

TJ Lockhart

Don Brinberg, MD

Jessica Balay

Adnan Ahmad

Valerie Fornili

Frederick Ruthardt

Tom Leuck

Vikas Dembla

LaMonica Connell

Kofi Nuako, MD

Ilimbek Beketaev Beketaev

Tanima Jana

Heather Wilson

Larry E Clark Jr., MD

Wendy Crawford

Pramod Malik, MD

The primary objective of this study is to collect de-identified, clinically-characterized stool and whole blood specimens for use in developing and evaluating the performance of new biomarker assays for the detection of colorectal cancer (CRC).

Participants will be 40 years of age or older, with a diagnosis of CRC, at any stage, confirmed with a tissue biopsy or a colorectal lesion at least 1 cm in size suspicious for adenoma (including sessile serrated adenoma) or CRC on a pre-enrollment colonoscopy, sigmoidoscopy, or computed tomography (CT) colonography. Approximately 1500 participants will be enrolled.

Specimens collected under this protocol may be stored indefinitely for future research in addition to and separate from the study and use of specimens and data described in the rest of this protocol. Specimens are de-identified of all protected health information and clinical study data will only be associated by a subject identification number. Specimens de-accessioned from the biorepository will be destroyed under standard biohazardous material protocol and record of the removal and destruction will be maintained for 7 years by the Sponsor. Specimens and/or data collected during this study may be used by the Sponsor and its affiliates and may also be shared with and used by other outside individuals and organizations.

Blood and Stool Sample Collection in Subjects With a Diagnosis of Colorectal Cancer or Colorectal Lesion: Act Fast

The outcomes are co-primary. Biomarkers under evaluation include differential methylation of nucleic acids and altered expression of proteins in stool from subjects with confirmed colorectal cancer at the pre-intervention stage.

The outcomes are co-primary. Biomarkers under evaluation include differential methylation of nucleic acids and altered expression of proteins in blood from subjects with confirmed colorectal cancer at the pre-intervention stage.

Individuals who are 40 years of age and older, eligible for CRC screening, and scheduled for a screening colonoscopy.

mt-sDNA 2.0 screening test

Stool samples will be collected by the subject for the FIT test.

FIT test

The primary objective of this study is to assess the sensitivity for colorectal cancer (CRC) and specificity of the mt-sDNA 2.0 test.

Subjects 40 years of age and older scheduled for a screening colonoscopy will be enrolled. Subject will complete the mt-sDNA 2.0 test and the commercially available FIT, followed by completion of a screening colonoscopy. The results of the mt-sDNA screening test and FIT will not be provided to investigators for clinical management of the study subject. Personnel performing the colonoscopy and producing the resulting report and personnel performing histopathologial review of reports or tissue (if applicable) will remain blinded to the results of the mt-sDNA 2.0 screening test results.

Residual stool samples will be used to develop and evaluate the performance of biomarker assays to detect cancers and advanced precancerous lesions. Samples may be stored for up to 20 years. These stool samples will be de-identified.

Clinical Validation of An Optimized Multi-Target Stool DNA (Mt-sDNA 2.0) Test, for Colorectal Cancer Screening "BLUE-C"

Individual participant data that underlie the results reported in publications of the study may be shared after de-identification. This may include text, tables, figures, and appendices. The study protocol, statistical analysis plan, and informed consent form may also be shared. Data may be shared with researchers who provide a methodologically sound proposal to achieve the aims outlined in the approved proposal.

Stool sample collection and blood draw in men and women aged 40 and older with average CRC risk undergoing a standard of care colonoscopy procedure

Stool sample collection and blood draw in men and women aged 40 and older with increased CRC risk undergoing a standard of care colonoscopy procedure

The primary objective of this study is to collect de-identified, clinically-characterized stool and whole blood specimens for use in developing and evaluating the performance of new biomarker assays for detection of colorectal cancer (CRC).

Subjects will be men and women, 40 years of age or older who are scheduled for a colonoscopy. Approximately 7,500 subjects will be enrolled.

Residual blood and stool samples may be used for evaluating performance of biomarkers for feasibility and assay development. Sample may be stored for up to 20 years. These blood and stool samples will be de-identified.

Blood and Stool Sample Collection in Subjects Participating in Colorectal Cancer Screening: Act Bold

Individual participant data that underlie the results reported in publications of the study will be shared after deidentification. This may include text, tables, figures and appendices. The study protocol and informed consent form will also be shared.

The outcomes are co-primary. Biomarkers under evaluation include differential methylation of nucleic acids and altered expression of proteins in stool from subjects at average risk or increased risk for development of colorectal cancer at the pre-intervention stage.

The outcomes are co-primary. Biomarkers under evaluation include differential methylation of nucleic acids and altered expression of proteins in blood from subjects at average risk or increased risk for development of colorectal cancer at the pre-intervention stage.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
An Evaluation of a Multi-target Stool DNA (Mt-sDNA) Test, Cologuard, for CRC Screening in Individuals Aged 45-49 and at Average Risk for Development of Colorectal Cancer: Act Now	NCT03728348	Colorectal Canc...	mt-sDNA screeni... Colonoscopy	45 Years - 49 Years	Exact Sciences Corporation
A Stool DNA Test for Detection of Advanced Colorectal Neoplasia in Asymptomatic Chinese Community Population	NCT04786704	Colorectal Canc... Colorectal Neop... Advanced Adenom... Adenoma Serrated Lesion	Stool-based SDC... quantitative Fe...	45 Years - 75 Years	Changhai Hospital
Blood and Stool Sample Collection in Subjects With a Diagnosis of Colorectal Cancer or Colorectal Lesion: Act Fast	NCT03789162	Colorectal Canc...		40 Years -	Exact Sciences Corporation
Blood and Stool Sample Collection in Subjects With a Diagnosis of Colorectal Cancer or Colorectal Lesion: Act Fast	NCT03789162	Colorectal Canc...		40 Years -	Exact Sciences Corporation
An Evaluation of a Multi-target Stool DNA (Mt-sDNA) Test, Cologuard, for CRC Screening in Individuals Aged 45-49 and at Average Risk for Development of Colorectal Cancer: Act Now	NCT03728348	Colorectal Canc...	mt-sDNA screeni... Colonoscopy	45 Years - 49 Years	Exact Sciences Corporation
Clinical Validation of An Optimized Multi-Target Stool DNA (Mt-sDNA 2.0) Test, for Colorectal Cancer Screening "BLUE-C"	NCT04144738	Colorectal Canc...	mt-sDNA 2.0 scr... FIT test Colonoscopy	40 Years -	Exact Sciences Corporation
A Stool DNA Test for Detection of Advanced Colorectal Neoplasia in Asymptomatic Chinese Community Population	NCT04786704	Colorectal Canc... Colorectal Neop... Advanced Adenom... Adenoma Serrated Lesion	Stool-based SDC... quantitative Fe...	45 Years - 75 Years	Changhai Hospital
Blood and Stool Sample Collection in Subjects Participating in Colorectal Cancer Screening: Act Bold	NCT03821948	Colorectal Canc...		40 Years -	Exact Sciences Corporation
Clinical Validation of An Optimized Multi-Target Stool DNA (Mt-sDNA 2.0) Test, for Colorectal Cancer Screening "BLUE-C"	NCT04144738	Colorectal Canc...	mt-sDNA 2.0 scr... FIT test Colonoscopy	40 Years -	Exact Sciences Corporation
Clinical Validation of An Optimized Multi-Target Stool DNA (Mt-sDNA 2.0) Test, for Colorectal Cancer Screening "BLUE-C"	NCT04144738	Colorectal Canc...	mt-sDNA 2.0 scr... FIT test Colonoscopy	40 Years -	Exact Sciences Corporation

Spots Global Cancer Trial Database for stool dna

Every month we try and update this database with for stool dna 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 stool dna

Every month we try and update this database with for stool dna 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 stool dna 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.