Role of Genomic Imprinting in Cancer Diagnosis

• Conditions: Genomic Imprinting; Cancer; Biomarker; Early Diagnosis
• Interventions: Diagnostic Test: In-situ imprinting detection

• Registration Number: NCT03882684
• Lead Sponsor: Chinese Alliance Against Lung Cancer

Brief Summary

The current research focus for cancer diagonosis is classical genetics, named "driving genes". However, not all cancer patients have typical genetic alterations, especially at early stage. In the past dacades, accumulating evidences have revealed that more than 80% diseases are closely related to epigenetic changes. The normally silenced copy of imprinted genes are reactivated at early stage of cancers, and finally proceed to copy number variation. This study will screen for a panel of imprinted genes and build quantitative models to assist the diagnosis of multiple cancers.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-07-01
• Status Verified: 2019-03
• Study First Submitted: 2019-03-18
• Study First Submitted QC: 2019-03-18
• Last Update Submitted: 2019-03-18
• Study First Posted: 2019-03-20
• Last Update Posted: 2019-03-20
• Primary Completion: 2019-03-31
• Study Completion: 2020-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1500

Inclusion Criteria

• Patients diagnosed with suspicious cancer by ultrasound, CT or endoscope.
• Biopsy samples available.
• Male or female patients aged ≥ 18 years.
• Participants signed informed consent form.

Exclusion Criteria

• Age under 18 years.
• Severe cardiovascular diseases.
• Central nervous system diseases.
• Mental disorder.
• Pregnant.
• Individuals unwilling to sign the IRB-approved consent form and unwilling to follow the protocol to submit the serial urine for test after surgery.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cancer patients	In-situ imprinting detection	The patients receive the surgery according to the indication of surgery. The diagnosis is confirmed by pathology of removed tissue. The result of imprinting detection are used as cancer group.
Benign tumor and other disease patients	In-situ imprinting detection	Patients ruled out the possibility of malignancy according to biopsy pathology are used as negative control.

Primary Outcome Measures

Name	Time	Method
Specificity of imprinting cancer early detection	In the middle of the study, an average of 15 months	Number of patients "declared negative" with the imprinting early detection among the patients who are with benign tumors or other diseases
Sensitivity of imprinting cancer early detection	In the middle of the study, an average of 15 months	Number of patients "declared positive" with the imprinting early detection among the patients suffered from cancer

Secondary Outcome Measures

Name	Time	Method
Comparison of the sensitivity of the imprinting detection versus cytopathology	In the middle of the study, an average of 15 months	Number of patients "declared positive" with the imprinting early detection versus patients "declared positive" with the cytopathology
Comparison of the specificity of the imprinting detection versus cytopathology	In the middle of the study, an average of 15 months	Number of patients "declared negative" with the imprinting early detection versus patients "declared negative" with the cytopathology

Trial Locations

Locations (1)

Zhongshan Hospital of Fudan University; 🇨🇳 Shanghai, Shanghai, China