Specific Molecular Signatures Predict Neoadjuvant Chemotherapy Response in Cervical Cancer

NCT03229187 | Unknown DMC

• 1 other identifier: 2016-NACT-01
• Study Type: observational
• Target: 240
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Uterine Cervical Neoplasms; Cervical Cancer; Uterine Cervical Cancer

Outcome Measures

Primary Outcomes (1)

• The clinical response to neoadjuvant chemotherapy

  clinical response（tumor size）

  1 to 3 months

Secondary Outcomes (1)

• The pathological response to neoadjuvant chemotherapy

  1 to 3 months

Study Arms (1)

neoadjuvant chemotherapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with histologically confirmed Ib\~ IIb cervical carcinoma underwent Neoadjuvant Chemotherapy

You may qualify if:

• 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

You may not qualify if:

• Previous history of cancer
• Patients with previous treatment
• Patients without information of clinical risk factors
• Patients who have active infection

Sponsors & Collaborators

• Huazhong University of Science and Technology: lead
• Zhejiang University: collaborator
• Wuhan Central Hospital: collaborator

Study Sites (1)

Tongji Hospital

Wuhan, Hubei, 430030, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Samples with DNA from blood and tissues.

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Central Study Contacts

Ma Ding, M.D.

CONTACT

86-27-8362681; dma@tjh.tjmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Department of Gynecology and Obstetrics

Study Record Dates

• First Submitted: July 20, 2017
• First Posted: July 25, 2017
• Study Start: January 1, 2016
• Primary Completion: September 30, 2020
• Study Completion: September 30, 2020
• Last Updated: June 16, 2020

Record last verified: 2020-06

Locations

CN (1)