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Molecular diagnostic characteristics in Cervical cancer: ROS1/ALK mutation biomarker study (MARC study)

Molecular diagnostic characteristics in Cervical cancer: ROS1/ALK mutation biomarker study (MARC study) - MARC study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000053405
Enrollment
250
Registered
2024-02-14
Start date
2024-04-01
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

Cervical cancer

Interventions

None listed

Sponsors

Japanes Gynecology Oncology Group
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

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

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
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.

Secondary

MeasureTime frame
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).

Countries

Japan

Contacts

Public Contacthiroko machida

Tokai University School of Medicine Department of Obstetrics and Gynecology

hiroko.machida@tokai.ac.jp463-93-1121

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026