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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. (see Contacts and Locations)
Verified May 2016 by Huazhong University of Science and Technology
Sponsor:
Collaborators:
Zhejiang University
Shandong University
Sun Yat-sen University
Wuhan University
Hubei Women and Children's Hospital
Wuhan General Hospital of Guangzhou Military Command
Xiangfan Central Hospital
Wuhan central hospital
Hubei University for nationalities
Information provided by (Responsible Party):
Ding Ma, Huazhong University of Science and Technology
ClinicalTrials.gov Identifier:
NCT01628757
First received: June 26, 2012
Last updated: May 13, 2016
Last verified: May 2016
  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: Cohort
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:


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

Primary Outcome Measures:
  • The clinical and pathological response to neoadjuvant chemotherapy [ Time Frame: 1 to 3 months ] [ Designated as safety issue: Yes ]
    including: ① clinical response(tumor size), ②pathological response(<3 mm or not), ③toxic response (degree) and so on.


Secondary Outcome Measures:
  • long-term response for patients undergoing neoadjuvant chemotherapy [ Time Frame: up to 10 years to 20 years or more ] [ Designated as safety issue: Yes ]
    including ① DFS, ②OS, ③long-term complications,④secondary diseases, ⑤life quality, ⑥long-term toxic effects caused by the treatment and so on.


Biospecimen Retention:   Samples With DNA
Samples with DNA from blood,TCT,pap smear,and hpv, as well as body fluid and tissues.

Estimated Enrollment: 1400
Estimated Study Completion Date: December 2023
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts
neoadjuvant chemotherapy

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Ding Ma
Zhejiang University
Shandong University
Sun Yat-sen University
Wuhan University
Hubei Women and Children's Hospital
Wuhan General Hospital of Guangzhou Military Command
Xiangfan Central Hospital
Wuhan central hospital
Hubei University for nationalities
  More Information

Responsible Party: Ding Ma, Prof. of Dept. of O & G, Huazhong University of Science and Technology
ClinicalTrials.gov Identifier: NCT01628757     History of Changes
Other Study ID Numbers: GM2011-07-01  CERVca02/2002 
Study First Received: June 26, 2012
Last Updated: May 13, 2016
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 December 02, 2016