A Stool DNA-based SDC2 Methylation Test for the Early Detection of Colorectal Cancer

Colorectal Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05255588
• Other study ID #: NEXT-CRC
• Status: Recruiting
• Start date: February 10, 2022
• Est. completion date: February 28, 2024

Study information

• Verified date: November 2023
• Source: Genomictree, Inc.
• Contact: TaeJeong Oh
• Phone: 82-42-861-4551
• Email: tjoh[@]genomictree.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2358
• Est. completion date: February 28, 2024
• Est. primary completion date: February 28, 2024
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenoma
• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Device:
• EarlyTect® CRC test
A highly accurate and sensitive real time PCR employing Linear Target Enrichment and Quantitative Methylation-Specific PCR (LTE/qMSP) for measuring SDC2 methylation in stool DNA to detect CRC.

Locations

Country	Name	City	State
Korea, Republic of	Soon Chun Hyang University Hospital Seoul	Seoul

Sponsors (15)

Lead Sponsor

Collaborator

Genomictree, Inc.

Asan Medical Center, Gangnam Severance Hospital, Kangbuk Samsung Hospital, Keimyung University Dongsan Medical Center, Korea University Anam Hospital, Kyung Hee University Hospital, Kyung Hee University Hospital at Gangdong, Pusan National University Hospital, Samsung Medical Center, Seoul National University Hospital, Severance Hospital, Soon Chun Hyang University, The Catholic Univ. of Korea Bucheon ST. Mary's Hospital, Wonju Severance Christian Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity and specificity of the EarlyTect® CRC test for detecting CRC compared to the colonoscopy, both in terms of detecting CRC.	The reference method is the colonoscopy, and lesions will be assessed histopathologically.; EarlyTect® CRC test includes a measurement of SDC2 methylation and COL2A1 as a DNA control. SDC2 methylation in stool DNA will be assessed quantitatively by LTE/qMSP. The results will be dichotomized by the CT (cycle threshold) cutoff value as either positive or negative. Sensitivity = 100*(positive SDC2 methylation test/positive colonoscopy), Specificity = 100*(negative SDC2 methylation test/negative colonoscopy).	18 months
Secondary	Sensitivity of EarlyTect® CRC for detecting advanced colorectal adenoma (Adenomas =1.0 cm, villous adenomas or high-grade dysplasia)	Sensitivity for detecting adenomas =1.0 cm; Sensitivity of EarlyTect® CRC for detecting villous adenomas; Sensitivity of EarlyTect® CRC for detecting high-grade dysplasia	18 months
Secondary	Sensitivity of EarlyTect® CRC for detecting advanced colorectal neoplasm	Sensitivity for detecting adenomas =1.0 cm	18 months
Secondary	Sensitivity of EarlyTect® CRC for detecting non-advanced adenomas	Sensitivity for detecting non-adenomas <1.0 cm	18 months
Secondary	Sensitivity and specificity of combined FIT and EarlyTect® CRC tests in detecting CRC	Sensitivity and specificity of combined FIT and EarlyTect® CRC tests in detecting CRC	18 months
Secondary	Sensitivity of EarlyTect® CRC for detecting advanced colorectal serrated lesions	Sensitivity of EarlyTect® CRC for detecting advanced colorectal serrated lesions	18 months
Secondary	Clinical specificity of EarlyTect® CRC when patients with non-advanced adenomas and non-advanced colorectal serrated lesions are included in control group	Clinical specificity of EarlyTect® CRC when patients with non-advanced adenomas and non-advanced colorectal serrated lesions are included in control group	18 months
Secondary	Clinical sensitivity of the EarlyTect® CRC for detecting Tis	Clinical sensitivity of the EarlyTect® CRC for detecting colorectal cancer with Tis	18 months