Evaluation of reproducibility for a biomarker as the prediction of prognosis after radiotherapy for the patients with cervical cancer

Evaluation of reproducibility for a biomarker as the prediction of prognosis after radiotherapy for the patients with cervical cancer - A biomarker as prediction of prognosis after radiotherapy

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000004467

Enrollment

150

Registered

2010-11-01

Start date

2012-04-01

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

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. The patient with histologically confirmed primary squamous cell carcinoma of the cervix uteri. 2. The patient with FIGO stage Ib-IVa (in 1994). 3. The patient with ECOG Performance Status (PS) of 0-2. 4. The patient aged between 20 and 85 years at the time of enrollment. 5. The patient without para-aortic lymph node metastasis. 6. The patient without a history of radiation therapy, chemotherapy, or surgical treatment for cervical cancer. 7. The patient who signed a written informed consent after thorough explanation and understanding of protocol requirements.

Exclusion criteria

Exclusion criteria: 1. The patient with cervical stump carcinoma. 2. The patient with active multiple primary cancer defined as synchronous multiple primary cancer and metachronous multiple cancer within 5 years of disease free survival. However, carcinoma in situ judged to be cured by local treatment is not to be included in multiple primary cancer. 3. The patient is pregnant, at risk of pregnancy, or lactating. 4. The patient wishing to become pregnant. 5. The patient with problems which would preclude participation in the study due to a complication of mental diseases or psychiatric symptoms. 6. The patient with serious complications (collagen diseases or uncontrollable diabetes) judged to hinder implementation of treatment. 7. The patient with chronic heart failure or a history of cardiovascular disease within the past 3 months. 8. The patient with a history of serious cerebrovascular disorder within the past 3 months. 9. The patient with active infection. 10. The patient with a pacemaker. 11. The patient with a positive HBsAg. 12. Other patients who were judged as being inappropriate as subjects for this study by investigator.

Design outcomes

Primary

Measure	Time frame
Progression-free survival	—

Secondary

Measure	Time frame
Overall survival Pelvic progression-free survival Distant metastasis-free survival	—

Countries

Japan

Contacts

Public ContactYoko Harima

Kansai Medical University, Takii Hospital Department of Radiology

harima@takii.kmu.ac.jp06-6992-1001

Outcome results