Cervical Cancer, Endometrial Cancer, Nasopharyngeal Carcinoma, Ovarian Cancer, Ovarian Clear Cell Carcinoma, Triple Negative Breast Cancer
Conditions
Keywords
ctDNA, Solid tumor in Asia
Brief summary
This study is a genetic analysis of aberrations in circulating tumor DNA (ctDNA) in patients in Asian countries. This study protocol is divided into parts describing several subanalyses that differ in terms of cancer types, analytical methods, participating countries, and participating institutions.
Detailed description
NGS analysis will be performed on cfDNA extracted from peripheral blood samples of target patients to determine the types and incidences of genetic abnormalities. Patient information and gene abnormality data will be integrated, and the types and incidences of gene abnormalities by cancer type will be analyzed.
Interventions
GENETICNGS analysis of ctDNA
Diagnostic Test: plasma circulating tumor DNA
Sponsors
National Cancer Center, Japan
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age of 18 years or older at registration. 2. Diagnosis of cancer which is targeted by each cohort. 3. Metastatic and/or recurrent disease.
Exclusion criteria
1. Any other malignancy within 3 years prior to registration, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the esophagus, stomach, colon, or cervix. 2. Ongoing chemotherapy. (Chemotherapy-naïve patients or awaiting initiation of the next line of chemotherapy are eligible. There is no limit on the number of prior chemotherapies or on the time from completion of chemotherapy to registration). 3. Ongoing radiation therapy. (There are no limits on the time from completion of radiation therapy to registration).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of patients with one or more genetic abnormalities among all examination cases | Through study completion, an average of 1 year | DNA may be extracted from blood or tumor tissue samples, and germline gene abnormality may be analyzed using techniques such as PCR, NGS, and Sanger sequencing. |
| Percentage of patients with each genetic abnormality among all examination cases | Through study completion, an average of 1 year | DNA may be extracted from blood or tumor tissue samples, and germline gene abnormality may be analyzed using techniques such as PCR, NGS, and Sanger sequencing. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Genomic abnormalities of ctDNA and tumor tissue will be combined to report the concordance rate | Through study completion, an average of 1 year | Concordance rate is defined by the sum of concordance on positives with the denominator as the total number of genes in which a genomic alteration is detected, i.e., genes in which alterations are not detected by one of assays are excluded from both the numerator and denominator. |
Countries
Japan, Malaysia, Philippines, Singapore, South Korea, Taiwan, Thailand, Vietnam
Outcome results
None listed