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

This study is currently recruiting participants.
Verified June 2012 by Huazhong University of Science and Technology
Sponsor:
Information provided by:
Huazhong University of Science and Technology
ClinicalTrials.gov Identifier:
NCT01628757
First received: June 26, 2012
Last updated: NA
Last verified: June 2012
History: No changes posted
  Purpose

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.


Condition
Cervical Cancer

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Model Development and Prospective Validation to Predict the Response to Neoadjuvant Chemotherapy in Cervical Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Huazhong University of Science and Technology:

Primary Outcome Measures:
  • The clinical and pathological response to neoadjuvant chemotherapy [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: July 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
neoadjuvant chemotherapy

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Previous history of cancer
  • Patients with previous treatment
  • Patients without information of clinical risk factors
  • Patients who have active infection
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01628757

Contacts
Contact: Ma Ding, M.D. 86-27-8362681 dma@tjh.tjmu.edu.cn

Locations
China, Hubei
Tongji Hospital Recruiting
Wuhan, Hubei, China, 430030
Contact: Ma Ding, M.D.     86-27-8362681     dma@tjh.tjmu.edu.cn    
Sponsors and Collaborators
Huazhong University of Science and Technology
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT01628757     History of Changes
Other Study ID Numbers: GM2011-07-01
Study First Received: June 26, 2012
Last Updated: June 26, 2012
Health Authority: China: Ministry of Health

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
 Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on May 23, 2013