UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053405 |
|---|---|
| Receipt number | R000060948 |
| Scientific Title | Molecular diagnostic characteristics in Cervical cancer: ROS1/ALK mutation biomarker study (MARC study) |
| Date of disclosure of the study information | 2024/02/14 |
| Last modified on | 2024/01/21 12:25:26 |
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Basic information
Public title
Molecular diagnostic characteristics in Cervical cancer:
ROS1/ALK mutation biomarker study (MARC study)
Acronym
MARC study
Scientific Title
Molecular diagnostic characteristics in Cervical cancer:
ROS1/ALK mutation biomarker study (MARC study)
Scientific Title:Acronym
MARC study
Region
| Japan |
Condition
Condition
Cervical cancer
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
This study aims to conduct an exploratory analysis to examine the molecular characteristics of cervical cancer, especially adenocarcinoma, in a Japanese population. We also aim to determine the association between target genes in cervical cancer and clinical outcomes. Specifically, we investigate the correlation between target genes (ROS1 gene, ALK gene) and prognosis, including progression-free survival time and overall survival time, in patients newly diagnosed with cervical cancer, based on target gene mutation frequency and site.
Basic objectives2
Others
Basic objectives -Others
An exploratory research of cervical adenocarcinoma-related genetic mutation profiles (ROS1, ALK, TP53, CDKN2A, STK11, KMT2D, EGFR, EP300, PIK3CA, KRAS, ARID1A, PTEN genes).
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To investigate the correlation between target genes (ROS1 gene, ALK gene) and target gene mutation frequency and prognosis (progression-free survival time, overall survival time) by site in patients newly diagnosed with cervical cancer.
Stratification by tumor histology to assess mutation frequency and location of target genes, particularly in adenocarcinoma, and examine their correlation with prognosis.
Key secondary outcomes
To assess the relationship between prognosis and treatment efficacy in the context of other cervical adenocarcinoma-related genetic mutation profiles (TP53, CDKN2A, STK11, KMT2D, EGFR, EP300, PIK3CA, KRAS, ARID1A, PTEN).
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1. Patients who can approve informed consent and sign it.
Patients who show their will to participate in this study and can sign the informed consent forms by themselves.
2. Patients who are clinically diagnosed with cervical cancer.
The histopathological diagnosis is based on the tumor removed by surgery or obtained by tissue biopsy before the start of treatment. (Excluding cytology)
Recruit for patients with adenocarcinomas of cervical cancer, including specific types, as well as squamous cell carcinomas.
3. Patients who can provide tumor tissue specimens
4. Patients who are 20 years old and over at the enrollment
Key exclusion criteria
1. Patients with active concomitant malignancy* except breast cancer.
*Includes synchronous multiple cancer and metachronous multiple cancer with less than 5 years of disease-free survival. However, excludes skin basal cell carcinoma, skin squamous cell carcinoma, and any other curable lesions with local therapy such as carcinoma in situ or intramucosal carcinoma.
2. Patients who are diagnosed with any other acute/chronic, physically/mentally severe diseases and judged by the primary physician as inappropriate to enroll in this study because of safety reasons or any influence on study outcomes.
3. Any other cases that are inappropriate to enroll in this study, judged by the study principal investigator.
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | hiroko |
| Middle name | |
| Last name | Machida |
Organization
Tokai University School of Medicine
Division name
Department of Obstetrics and Gynecology
Zip code
259-1193
Address
143 Shimokasuya, Isehara, Kanagawa
TEL
463-93-1121
hiroko.machida@tokai.ac.jp
Public contact
Name of contact person
| 1st name | hiroko |
| Middle name | |
| Last name | machida |
Organization
Tokai University School of Medicine
Division name
Department of Obstetrics and Gynecology
Zip code
259-1193
Address
143 Shimokasuya, Isehara, Kanagawa
TEL
463-93-1121
Homepage URL
hiroko.machida@tokai.ac.jp
Sponsor or person
Institute
Japanes Gynecology Oncology Group
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency (JST)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Japanes Gynecology Oncology Group
Address
6 Chome-24 Kagurazaka, Shinjuku City, Tokyo
Tel
03-5206-1982
info@jgog.gr.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 02 | Month | 14 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2024 | Year | 02 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We are currently in the process of recruiting institutions to participate in our research. Additionally, we are conducting a crowdfunding campaign.
Management information
Registered date
| 2024 | Year | 01 | Month | 21 | Day |
Last modified on
| 2024 | Year | 01 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060948
