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SDC2 methylation assay by qPCR using EarlyTect Colon Cancer kit

EarlyTect Colon Cancer

Pivotal trials of SDC2 methylation biomarker test in stool DNA to estimate clinical sensitivity and specificity in detection of colorectal cancer.

The purpose of this study is to validate the clinical performance of EarlyTect Colon Cancer test which is measuring Syndecan 2 methylation status in stool DNA to detect CRC. Syndecan 2 (SDC2) is a newly developed methylation biomarker for colorectal cancer diagnosis. Methylation status of SDC2 gene in stool DNA is determined by methylation specific qPCR. Sensitivity and specificity will be determined by comparing Stool DNA test from healthy subjects, CRC patients, and other group including polyps and other diseases.

Clinical Validation of Stool DNA-based SDC2 Methylation Test for Colorectal Cancer Detection

Clinical Study for the Validation of Real Time qPCR for SDC2 Methylation in Stool DNA for Early Detection of Colorectal Cancer

Sensitivity and specificity of EarlyTect Colon Cancer to detect colorectal cancer (sensitivity: the ratio of positive cases in all CRC cases, specificity: the ratio of negative cases in all healthy controls)

the ratio of SDC2 methylation positive in polyps

the ratio of SDC2 methylation positive in other cancers

Severance Hospital

Genomictree, Inc.

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Urinary Bladder Neoplasms

Hematuria

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urinary Bladder Diseases

Urologic Diseases

Male Urogenital Diseases

Urination Disorders

Hemorrhage

Device: EarlyTect Bladder Cancer test, PENK methylation assay by LTE (Linear Target Enrichment)-qMSP (quantitative methylation-specific real time PCR)

A highly accurate and sensitive real-time PCR employing Linear Target Enrichment and Quantitative Methylation-Specific PCR (LTE-qMSP) for measuring PENK methylation in urine DNA to detect bladder cancer in hematuria patients.

EarlyTect® Bladder Cancer test

Cheol Kwak, MD PhD

In Gab Jeong, MD PhD

The primary objective of this clinical trial is to determine the sensitivity and specificity of the EarlyTect® Bladder Cancer test for bladder cancer among patients with hematuria by comparing it to the results of cystoscopy examinations.

The second objective is to compare the clinical performance of EarlyTect® Bladder Cancer test with a NMP22 test and urine cytology test with respect to bladder cancer. By histopathological examination, lesions identified during cystoscopy will be confirmed as malignant or non-malignant by histological examination.

Patients with hematuria who are scheduled for cystoscopy will be asked to collect a urine sample for EarlyTect® Bladder Cancer test and will undergo NMP22 and urine cytology tests. The participants will undergo a cystoscopy within 30 days of enrollment. For confirmation of the diagnosis and stage of the tumor, representative histopathology slides from TURBT (Transurethral Resection of Bladder Tumors) may be retrieved and examined by the central pathology laboratory.

Residual urine samples may be archived for further research. Clinical data and samples will be kept in a manner that preserves anonymity of the subjects, using the subject ID as the only tracking information. Specimens will be stored at Genomictree and may be used for future research.

PENK Methylation Test for Detecting Bladder Cancer

A Multicenter, Single-blind, Prospective Clinical Trial to Evaluate the Clinical Performance of EarlyTect® Bladder Cancer Test in the Urine DNA for Detecting Bladder Cancer Among Hematuria Patients

Comparison of clinical sensitivity and specificity to the NMP22 test

Comparison of clinical sensitivity and specificity to the urine cytology test

Sensitivity of EarlyTect® Bladder Cancer test for detecting bladder cancer with stages CIS and Ta low-grade

Positive predictive value and negative predictive value of EarlyTect® Bladder Cancer test for detecting bladder cancer

Clinical sensitivity and specificity in the combination of EarlyTect® Bladder Cancer and NMP22 tests for detecting bladder cancer

Clinical sensitivity and specificity in the combination of EarlyTect® Bladder Cancer and cytology tests for detecting bladder cancer

Clinical sensitivity and specificity in the combination of EarlyTect® Bladder Cancer, NMP22, and cytology tests for detecting bladder cancer

Sensitivity and specificity of the EarlyTect® Bladder Cancer test for detecting bladder cancer (Stages Ta high-grade and T1-T4) in patients with hematuria compared to the cystoscopy examination, both in terms of detecting bladder cancer. The reference method is the cystoscopic procedure, and lesions will be assessed histopathologically.

EarlyTect® Bladder Cancer test includes a measurement of PENK methylation and COL2A1 as a DNA control.

PENK methylation in urine DNA will be assessed quantitatively by Linear Target Enrichment-coupled Quantitative Methylation-Specific PCR (LTE-qMSP) using the Real-time PCR method. The results will be dichotomized by the CT (cycle threshold) cutoff value as either positive or negative. Sensitivity = 100\*(positive PENK methylation test/positive cystoscopy), Specificity = 100\*(negative PENK methylation test/negative cystoscopy).

The performance of the EarlyTect® Bladder Cancer test in detecting Bladder cancer in hematuria patients will be compared with those of the NMP22 and urine cytology tests.

Seoul National University Hospital

Korea University Anam Hospital

National Cancer Center, Korea

Pusan National University Hospital

Samsung Medical Center

Ajou University School of Medicine

Ulsan University Hospital

Chonnam National University Hospital

Seoul Clinical Laboratories

Seoul National University Bundang Hospital

Asan Medical Center

Professor

Adenoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Subjects who are at high-risk (Asia Pacific Colorectal Screening Score ≥4.0) of developing CRC aged ≥40

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.

EarlyTect® CRC test

TaeJeong Oh

Hyun Gun Kim, MD PhD

Jaeyoung Chun, MD PhD

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.

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).

Residual stool samples may be archived for further research. Clinical data and samples will be kept in a manner that preserves anonymity of the subjects, using the subject ID as the only tracking information. Specimens will be stored at Genomictree and may be used for future research.

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

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

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).

Sensitivity for detecting adenomas ≥1.0 cm

* Sensitivity of EarlyTect® CRC for detecting villous adenomas
* Sensitivity of EarlyTect® CRC for detecting high-grade dysplasia

Sensitivity for detecting adenomas ≥1.0 cm

Sensitivity for detecting non-adenomas \<1.0 cm

Sensitivity and specificity of combined FIT and EarlyTect® CRC tests in detecting CRC

Sensitivity of EarlyTect® CRC for detecting advanced colorectal serrated lesions

Clinical specificity of EarlyTect® CRC when patients with non-advanced adenomas and non-advanced colorectal serrated lesions are included in control group

Clinical sensitivity of the EarlyTect® CRC for detecting colorectal cancer with Tis

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Clinical Validation of Stool DNA-based SDC2 Methylation Test for Colorectal Cancer Detection	NCT03146520	Colorectal Canc... Polyps Other Cancers Healthy	EarlyTect Colon...	30 Years - 80 Years	Genomictree, Inc.
PENK Methylation Test for Detecting Bladder Cancer	NCT05220189	Bladder Cancer Hematuria; Beni...	EarlyTect® Blad...	40 Years -	Asan Medical Center
PENK Methylation Test for Detecting Bladder Cancer	NCT05220189	Bladder Cancer Hematuria; Beni...	EarlyTect® Blad...	40 Years -	Asan Medical Center
A Stool DNA-based SDC2 Methylation Test for the Early Detection of Colorectal Cancer	NCT05255588	Colorectal Canc... Advanced Colore... Advanced Adenom... Non-neoplastic ... Non-advanced Ad...	EarlyTect® CRC ...	40 Years -	Genomictree, Inc.

Spots Global Cancer Trial Database for methylation biomarker