Cervical CancerA-TRAINNCT05099978
Asian Multicenter Prospective Study of ctDNA Sequencing
An observational study of Cervical Cancer and Ovarian Clear Cell Carcinoma, run by National Cancer Center, Japan at 19 sites in 8 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cervical Cancer, Ovarian Clear Cell Carcinoma, Nasopharyngeal Carcinoma
- What is being tested?
- NGS analysis of ctDNA
- How many people
- 506 participants
- Where
- 19 sitesin 8 countries
- Study dates
- 1 Nov 2021to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with metastatic and/or recurrent solid cancer which is targeted by each cohort in Asia.
Who may be able to join
- Age of 18 years or older at registration.
- Diagnosis of cancer which is targeted by each cohort.
- Metastatic and/or recurrent disease.
Who cannot join
- 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).
Trial locations and contacts
19 sites in 8 countries.
19 sites in 8 countries
Thailand7 sites
Vajira Hospital
Bangkok, 10300
Chulalongkorn University
Bangkok, 10330
Faculty of Medicine Ramathibodi Hospital, Mahidol University
Bangkok, 10400
Phramongkutklao Hospital
Bangkok, 10400
Mahidol University by Faculty of Medicine, Siriraj Hospital
Bangkok, 10700
Chiang Mai University
Chiang Mai, 50200
Songklanagarind Hospital
Songkhla, 90110
Malaysia4 sites
University Malaya Medicine Centre
Kuala Lumpur, Selangor, 59100
Hospital Kuala Lumpur
Kuala Lumpur, 50586
Sarawak General Hospital
Kuching, Sarawak, 93586
Institut Kanser Negara
Putrajaya, 62250
Singapore2 sites
National Cancer Centre of Singapore
Bukit Merah, 168582
National University Hopital
Kent Ridge, 119228
Vietnam2 sites
K Hospital
Hanoi
Ho Chi Minh City Oncology Hospital
Ho Chi Minh City
South Korea1 site
Severance Hospital, Yonsei University Health System
Seoul, 03722
Taiwan1 site
National Taiwan University Hospital
Taipei, Zhongzheng Dist, 100225
About this study
Official title: Asian Multicenter Prospective Study of Circulating Tumor DNA Sequencing: A-TRAIN
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.
Read the 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.
- Conditions
- Cervical Cancer, Ovarian Clear Cell Carcinoma, Nasopharyngeal Carcinoma, Ovarian Cancer, Endometrial Cancer, Triple Negative Breast Cancer
- Being tested
- NGS analysis of ctDNA
- Keywords
- ctDNA, Solid tumor in Asia
- Medical subject headings
- Uterine Cervical Neoplasms, Nasopharyngeal Carcinoma, Ovarian Neoplasms, Endometrial Neoplasms, Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NGS analysis of ctDNAGenetic
Diagnostic Test: plasma circulating tumor DNA
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Genetic: NGS analysis of ctDNA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with one or more genetic abnormalities among all examination cases
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.
Measured: Through study completion, an average of 1 year
Percentage of patients with each genetic abnormality among all examination cases
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.
Measured: Through study completion, an average of 1 year
Secondary outcomes (1)
Genomic abnormalities of ctDNA and tumor tissue will be combined to report the concordance rate
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.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2021
- Study start1 Nov 2021
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 506 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Center, Japan
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Kan Yonemori, MD, PhD, Principal investigator, Department of Medical Oncology, National Cancer Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05099978
- Sponsor's protocol ID
- NCCH1905
- Acronym
- A-TRAIN
- Status last verified
- Oct 2023
- First submitted
- 21 Sep 2021
- Last updated
- 4 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Asian Multicenter Prospective Study of Circulating Tumor DNA Sequencing: A-TRAIN
- ClinicalTrials.gov ID
- NCT05099978
- Acronym / sponsor ID
- A-TRAIN / NCCH1905
- Conditions
- Cervical Cancer, Ovarian Clear Cell Carcinoma, Nasopharyngeal Carcinoma, Ovarian Cancer, Endometrial Cancer, Triple Negative Breast Cancer
- Keywords
- ctDNA, Solid tumor in Asia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 506 participants (estimated)
- Lead sponsor
- National Cancer Center, JapanOther government
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 29 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NGS analysis of ctDNA | – | Genetic: NGS analysis of ctDNAThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with metastatic and/or recurrent solid cancer which is targeted by each cohort in Asia.
Key inclusion criteria (3 listed)
- Age of 18 years or older at registration.
- Diagnosis of cancer which is targeted by each cohort.
- Metastatic and/or recurrent disease.
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NGS analysis of ctDNADiagnostic Test: plasma circulating tumor DNA | Genetic | NGS analysis of ctDNA |
Primary outcome
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.
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kan Yonemori, MD, PhD principal investigator
Department of Medical Oncology, National Cancer Cancer Hospital
19 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Cancer and Ovarian Clear Cell Carcinoma, run by National Cancer Center, Japan at 19 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in Thailand, Malaysia, Singapore, Vietnam, Japan and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients with one or more genetic abnormalities among all examination cases (time frame: Through study completion, an average of 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2024.