Clinical trial NCT05255588: A Stool DNA-based SDC2 Methylation Test for the Early Detection of Colorectal Cancer
Official title: A Multicenter, Single-blind, Prospective Clinical Trial to Evaluate the Clinical Performance of EarlyTect® CRC Test for the Early Detection of Colorectal Cancer in the Stool DNA From High-risk Group
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Advanced Colorectal Neoplasm
Advanced Adenomas
Non-neoplastic Polyps
Non-advanced Adenomas
Keywords: Colorectal cancer
SDC2
Methylation biomarker
EarlyTect® CRC test
Stool
Lead sponsor: Genomictree, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Soon Chun Hyang University
name: Gangnam Severance Hospital
name: Kyung Hee University Hospital at Gangdong
name: Kangbuk Samsung Hospital
name: Kyung Hee University Hospital
name: Keimyung University Dongsan Medical Center
name: Korea University Anam Hospital
name: Pusan National University Hospital
name: The Catholic Univ. of Korea Bucheon ST. Mary's Hospital
name: Samsung Medical Center
name: Seoul National University Hospital
name: Asan Medical Center
name: Wonju Severance Christian Hospital
name: Severance Hospital
First posted: 2022-02-24
Enrollment: 2358
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who are at high-risk (Asia Pacific Colorectal Screening Score ≥4.0) of developing CRC

Brief summary: The primary objective of this clinical trial is to determine the sensitivity and specificity of the EarlyTect® CRC test for detecting CRC, using colonoscopy as the reference method.

The secondary objective is to compare the clinical performance of EarlyTect® CRC test with a commercially available Fecal Immunochemical Test (FIT), with respect to CRC. By histopathological examination, lesions identified during colonoscopy will be confirmed as malignant or precancerous by histological examination.

Detailed description: A multicenter, single-blind, prospective clinical trial is being conducted to evaluate the clinical performance of EarlyTect® CRC test. Subjects who are at high-risk (Asia Pacific Colorectal Screening Score ≥4.0) of developing CRC who are eligible for inclusion criteria will be asked to collect a stool sample and EarlyTect® CRC and FIT tests will be performed. For confirmation of the diagnosis and tumor staging, representative histopathology slides obtained from curative surgery and representative histopathology slides from tissue biopsied or excised during colonoscopy may be retrieved and examined by the central pathology laboratory. Methylation status of SDC2 in stool DNA is measured by a highly accurate and sensitive real time PCR that employs Linear Target Enrichment (LTE) and quantitative Methylation-Specific PCR (qMSP)(LTE-qMSP).

Eligibility criteria: Inclusion Criteria:

Subjects enrolled into the study must meet the following criteria:

* Individuals who agree to voluntarily sign an informed consent prior to the initiation of screening
* Adults aged ≥ 40 years
* Subjects who are at high-risk (Asia Pacific Colorectal Screening (APCS) Score: 4.0\~7.0) of developing CRC
* Subjects who are able and willing to undergo colonoscopy screening within 12 months of consent among individuals who reserved a visit in the division of gastroenterology or health check-up.

Exclusion Criteria:

Subjects will be excluded from enrolling into the study if any of the following criteria are met:

* Individuals who do not agree to voluntarily sign an informed consent prior to the initiation of screening
* Adults aged \< 40 years
* Subjects who are not at high-risk (APCS Score ≤ 3.0) of developing CRC
* Subjects who will not undergo colonoscopy screening within 12 months of consent
* Subjects who have had a positive FIT or fecal occult blood test within the previous 2 weeks
* Colorectal cancer patients who did not underwent curative treatment
* Subjects who have had a prior history of colorectal resection
* Subjects who have had overt rectal bleeding or melena within the previous 2 weeks
* Subjects who have a family history or a prior history of hereditary CRC or colorectal neoplasm: Lynch syndrome (HNPCC), familial adenomatous polyposis, MUTYH-associated polyposis, Juvenile polyposis syndrome, Peutz-Jeghers syndrome, and serrated polyposis syndrome, etc.
* Subjects who have inflammatory bowel diseases including Crohn's disease, ulcerative colitis or Behcet disease
* Subjects who participated in any "interventional" clinical study within the previous 30 days
* Subject has any condition which, in the opinion of the medical staff should preclude participation in the study

Primary outcomes:
measure: Sensitivity and specificity of the EarlyTect® CRC test for detecting CRC compared to the colonoscopy, both in terms of detecting CRC.
timeFrame: 18 months
Secondary outcomes:
measure: Sensitivity of EarlyTect® CRC for detecting advanced colorectal adenoma (Adenomas ≥1.0 cm, villous adenomas or high-grade dysplasia)
timeFrame: 18 months
measure: Sensitivity of EarlyTect® CRC for detecting advanced colorectal neoplasm
timeFrame: 18 months
measure: Sensitivity of EarlyTect® CRC for detecting non-advanced adenomas
timeFrame: 18 months
measure: Sensitivity and specificity of combined FIT and EarlyTect® CRC tests in detecting CRC
timeFrame: 18 months
measure: Sensitivity of EarlyTect® CRC for detecting advanced colorectal serrated lesions
timeFrame: 18 months
measure: Clinical specificity of EarlyTect® CRC when patients with non-advanced adenomas and non-advanced colorectal serrated lesions are included in control group
timeFrame: 18 months
measure: Clinical sensitivity of the EarlyTect® CRC for detecting Tis
timeFrame: 18 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Soon Chun Hyang University Hospital Seoul
Study officials:
References:
citation: Oh TJ, Oh HI, Seo YY, Jeong D, Kim C, Kang HW, Han YD, Chung HC, Kim NK, An S. Feasibility of quantifying SDC2 methylation in stool DNA for early detection of colorectal cancer. Clin Epigenetics. 2017 Dec 4;9:126. doi: 10.1186/s13148-017-0426-3. eCollection 2017.
citation: Han YD, Oh TJ, Chung TH, Jang HW, Kim YN, An S, Kim NK. Early detection of colorectal cancer based on presence of methylated syndecan-2 (SDC2) in stool DNA. Clin Epigenetics. 2019 Mar 15;11(1):51. doi: 10.1186/s13148-019-0642-0.