Role of Genomic Imprinting in Cancer Diagnosis

Chinese Alliance Against Lung Cancer

Status: Unknown

Conditions: Genomic Imprinting; Early Diagnosis; Biomarker; Cancer

Treatments: Diagnostic Test: In-situ imprinting detection

Study type: Observational

Funder types: Other

Identifiers

NCT03882684

CAALC-005-LiSen

Details and patient eligibility

About

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.

Enrollment: 1,500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

1,500 participants in 2 patient groups

Cancer patients

Description:

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.

Treatment:

Diagnostic Test: In-situ imprinting detection

Benign tumor and other disease patients

Description:

Patients ruled out the possibility of malignancy according to biopsy pathology are used as negative control.

Treatment:

Diagnostic Test: In-situ imprinting detection