Asian Multicenter Prospective Study of ctDNA Sequencing (A-TRAIN)
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| ClinicalTrials.gov Identifier: NCT05099978 |
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Recruitment Status :
Recruiting
First Posted : October 29, 2021
Last Update Posted : October 24, 2023
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Sponsor:
National Cancer Center, Japan
Information provided by (Responsible Party):
National Cancer Center, Japan
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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.
| Condition or disease | Intervention/treatment |
|---|---|
| Cervical Cancer Ovarian Clear Cell Carcinoma Nasopharyngeal Carcinoma Ovarian Cancer Endometrial Cancer Triple Negative Breast Cancer | Genetic: NGS analysis of ctDNA |
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.
| Study Type : | Observational |
| Estimated Enrollment : | 506 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Asian Multicenter Prospective Study of Circulating Tumor DNA Sequencing: A-TRAIN |
| Actual Study Start Date : | November 1, 2021 |
| Estimated Primary Completion Date : | December 31, 2024 |
| Estimated Study Completion Date : | December 31, 2024 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Breast cancer
MedlinePlus related topics:
Asian American Health
| Group/Cohort | Intervention/treatment |
|---|---|
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NGS analysis of ctDNA
This study consists of 6 cohorts; cervical cancer(n=100), ovarian clear cell cancer(n=50), nasopharyngeal cancer(n=96), ovarian cancer(n=100), breast cancer(n=100), endometrial cancer(n=60). In each cohort, the blood samples will be collected within 2weeks after registration. ctDNA will be extracted from blood samples and somatic gene abnormalities will be analyzed using NGS, PCR, and Sanger sequencing. In addition, the analysis of DNA methylation and RNA sequencing may be performed to obtain information related to gene expression. |
Genetic: NGS analysis of ctDNA
Diagnostic Test: plasma circulating tumor DNA |
Primary Outcome Measures :
- Percentage of patients with one or more genetic abnormalities among all examination cases [ Time Frame: 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 [ Time Frame: 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 Outcome Measures :
- Genomic abnormalities of ctDNA and tumor tissue will be combined to report the concordance rate [ Time Frame: 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.
Biospecimen Description:
Peripheral blood sample and unstained 5-micron formalin-fixed paraffin-embedded (FFPE) tumor tissue section
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
Patients with metastatic and/or recurrent solid cancer which is targeted by each cohort in Asia.
Criteria
Inclusion Criteria:
- Age of 18 years or older at registration.
- Diagnosis of cancer which is targeted by each cohort.
- Metastatic and/or recurrent disease.
Exclusion Criteria:
- 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.
- 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).
- Ongoing radiation therapy. (There are no limits on the time from completion of radiation therapy to registration).
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05099978
Contacts
| Contact: Kan Yonemori, MD, PhD | +81-3-3542-2511 | NCCH1905@ml.res.ncc.go.jp |
Locations
Show 19 study locations
Sponsors and Collaborators
National Cancer Center, Japan
Investigators
| Principal Investigator: | Kan Yonemori, MD, PhD | Department of Medical Oncology, National Cancer Cancer Hospital |
| Responsible Party: | National Cancer Center, Japan |
| ClinicalTrials.gov Identifier: | NCT05099978 |
| Other Study ID Numbers: |
NCCH1905 |
| First Posted: | October 29, 2021 Key Record Dates |
| Last Update Posted: | October 24, 2023 |
| Last Verified: | October 2023 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by National Cancer Center, Japan:
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ctDNA Solid tumor in Asia |
Additional relevant MeSH terms:
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Carcinoma Endometrial Neoplasms Triple Negative Breast Neoplasms Nasopharyngeal Carcinoma Adenomyoepithelioma Adenocarcinoma, Clear Cell Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms by Site Genital Diseases, Female Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Urogenital Diseases Genital Neoplasms, Female |
Urogenital Neoplasms Genital Diseases Uterine Neoplasms Uterine Diseases Breast Neoplasms Breast Diseases Skin Diseases Nasopharyngeal Neoplasms Pharyngeal Neoplasms Otorhinolaryngologic Neoplasms Head and Neck Neoplasms Nasopharyngeal Diseases Pharyngeal Diseases Stomatognathic Diseases Otorhinolaryngologic Diseases |