Integrated analysis of genomic and epigenomic alterations in circulating tumor DNA in patients with biliary tract cancer

Integrated analysis of genomic and epigenomic alterations in circulating tumor DNA in patients with biliary tract cancer - COSMOS-BTC-01

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000052780

Enrollment

110

Registered

2023-11-14

Start date

2024-03-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Biliary tract cancer

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.18 years of age or older 2.Clinically diagnosed with biliary tract cancer with one of the following in the UICC TNM classification, 8th edition. a. Intrahepatic cholangiocarcinoma, clinical stage I (T1N0M0) to IV (AnyTAnyNM1) b. Hilar cholangiocarcinoma, clinical stage 0 (TisN0M0) to IVB (AnyTAnyNM1) c. Distal cholangiocarcinoma, clinical stage 0 (TisN0M0) to IIIB (T4AnyNM0) d. Gallbladder cancer, clinical stage 0 (TisN0M0) to IVB (AnyTAnyNM1) e. Papilla Vater carcinoma , clinical stage 0 (TisN0M0) to IIIB (T4AnyNM0) 3.Resection of biliary tract cancer in 2 is planned. 4.Complete resection (R0/1 resection) is deemed possible. 5.No previous treatment for biliary tract cancer. 6.Willing to submit blood and tissue samples according to the study protocol 7.Written consent has been obtained.

Exclusion criteria

Exclusion criteria: 1.History of malignancy with a disease-free period of 5 years or less. *1 2.Clinically suspected coexistence of cancer of other organs. 3.Women who are pregnant or intend to become pregnant. 4.Judged by physician to be unsuitable for enrolment in the study. *1Pre-existing cancer with a disease-free interval of less than 5 years, but with a 5-year relative survival equivalent to 95% or more, such as stage I prostate cancer, stage 0 or stage I laryngeal cancer with a complete response to radiotherapy, or cancer of the following pathological stages that has been completely resected, will not be excluded and will be eligible for enrolment. Gastric cancer (adenocarcinoma [general type]): Stage 0 - Stage I Colorectal cancer (adenocarcinoma): Stage 0 - Stage I Esophageal cancer (flat epithelial carcinoma, adeno flat epithelial carcinoma, basaloid carcinoma): Stage 0 Breast cancer (non-invasive ductal carcinoma, non-invasive lobular carcinoma): stage 0 Breast cancer (invasive ductal carcinoma, invasive lobular carcinoma, Paget's disease): stage 0-IIA Uterine body cancer (endometrioid adenocarcinoma, mucinous adenocarcinoma): stage IA Anterior adenocarcinoma (adenocarcinoma): Stage I - IIA Cervical Cancer (Flat Epithelial Carcinoma): Stage IA Thyroid Cancer (Breast Cancer, Follicular Cancer): Stage I, II, III Kidney Cancer (Haplocellular Carcinoma, Haplocellular Carcinoma): Stage I Other Intramucosal Cancer Comparable Transformation

Design outcomes

Primary

Measure	Time frame
Positive rates of GUARDANT assays in resectable biliary tract cancer	—

Countries

Japan

Contacts

Public ContactYoshiaki Nakamura

National Cancer Center Hospital East Division for the Promotion of Drug and Diagnostic Development

yoshinak@east.ncc.go.jp04-7133-1111

Outcome results