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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03229187
Other study ID # 2016-NACT-01
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2016
Est. completion date September 30, 2020

Study information

Verified date June 2020
Source Huazhong University of Science and Technology
Contact Ma Ding, M.D.
Phone 86-27-8362681
Email dma@tjh.tjmu.edu.cn
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Cervical cancer is one of the major health problems for chinese women. Besides surgery and radiotherapy, neoadjuvant chemotherapy has been proved to be an effective program by many studies.

However, not all patients respond well to neoadjuvant chemotherapy. Knowing the therapeutic effect of the neoadjuvant chemotherapy before receiving it can not only reduce the economic burden, but also more importantly save time to take more suitable treatments.

This study is undertaken to build specific molecular signatures to predict the effects of neoadjuvant chemotherapy.


Recruitment information / eligibility

Status Recruiting
Enrollment 240
Est. completion date September 30, 2020
Est. primary completion date September 30, 2020
Accepts healthy volunteers
Gender Female
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- Untreated cervical cancer with FIGO stage Ib-IIb

- Measurable lesions

- Possible to radical hysterectomy

- Age: 18 and older

- Karnofsky Performance Status= 70.

- WBC > 3,000/mm³, Hb > 9.0g/dl, Platelet > 100,000 /mm³, SGOT/SGPT < 60 IU/L, T-Bil < 1.5 mg/dL, Cr < 1.2 mg/dL, PaO2 > 80 torr, normal ECG

- Written informed consent

Exclusion Criteria:

- Previous history of cancer

- Patients with previous treatment

- Patients without information of clinical risk factors

- Patients who have active infection

Study Design


Locations

Country Name City State
China Tongji Hospital Wuhan Hubei

Sponsors (3)

Lead Sponsor Collaborator
Huazhong University of Science and Technology The Central Hospital of Wuhan, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary The clinical response to neoadjuvant chemotherapy clinical response(tumor size) 1 to 3 months
Secondary The pathological response to neoadjuvant chemotherapy pathological response(<3 mm or not) 1 to 3 months
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