Model Development and Prospective Validation to Predict the Response to Neoadjuvant Chemotherapy in Cervical Cancer

NCT01628757 | Unknown DMC

• 2 other identifiers: GM2011-07-01CERVca02/2002
• Study Type: observational
• Target: 1,400
• 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 a model combine both clinical and genetic factors to predict the effects of neoadjuvant chemotherapy.

Conditions

Cervical Cancer

Outcome Measures

Primary Outcomes (1)

• The clinical and pathological response to neoadjuvant chemotherapy

  including: ① clinical response（tumor size）, ②pathological response（\<3 mm or not）, ③toxic response (degree) and so on.

  1 to 3 months

Secondary Outcomes (1)

• long-term response for patients undergoing neoadjuvant chemotherapy

  up to 10 years to 20 years or more

Study Arms (1)

neoadjuvant chemotherapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• Untreated cervical cancer with FIGO stage Ib-IIIb
• 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

• Ding Ma: lead
• Zhejiang University: collaborator
• Shandong University: collaborator
• Sun Yat-sen University: collaborator
• Wuhan University: collaborator
• Hubei Women and Children's Hospital: collaborator
• Wuhan General Hospital of Guangzhou Military Command: collaborator
• Xiangfan Central Hospital: collaborator
• Wuhan Central Hospital: collaborator
• Hubei University for nationalities: collaborator

Study Sites (1)

Tongji Hospital

Wuhan, Hubei, 430030, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Samples with DNA from blood,TCT,pap smear,and hpv, as well as body fluid 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: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. of Dept. of O & G

Study Record Dates

• First Submitted: June 26, 2012
• First Posted: June 27, 2012
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2023
• Last Updated: May 17, 2016

Record last verified: 2016-05

Locations

CN (1)