Specific Molecular Signatures Predict Neoadjuvant Chemotherapy Response in Cervical Cancer

Accurate Prediction and Validation of Response to Neoadjuvant Chemotherapy in Cervical Cancer

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.

Study Overview

• Status: Unknown
• Conditions: Cervical Cancer; Uterine Cervical Neoplasms; Uterine Cervical Cancer

• Study Type: Observational
• Enrollment (Anticipated): 240

Contacts and Locations

• Study Contact: Name: Ma Ding, M.D.; Phone Number: 86-27-8362681; Email: dma@tjh.tjmu.edu.cn

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Recruiting
      • Tongji Hospital
      • Contact: Ma Ding, M.D.; Phone Number: 86-27-8362681; Email: dma@tjh.tjmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
neoadjuvant chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The clinical response to neoadjuvant chemotherapy	clinical response（tumor size）	1 to 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The pathological response to neoadjuvant chemotherapy	pathological response（<3 mm or not）	1 to 3 months

Collaborators and Investigators

• Sponsor: Huazhong University of Science and Technology
• Collaborators: Zhejiang University; Wuhan Central Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Anticipated): September 30, 2020
• Study Completion (Anticipated): September 30, 2020

Study Registration Dates

• First Submitted: July 20, 2017
• First Submitted That Met QC Criteria: July 24, 2017
• First Posted (Actual): July 25, 2017

Study Record Updates

• Last Update Posted (Actual): June 16, 2020
• Last Update Submitted That Met QC Criteria: June 11, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Diseases; Uterine Cervical Neoplasms
• Other Study ID Numbers: 2016-NACT-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No