Clinical Trials Logo
  1. Home
  2. Cervical Cancer
  3. NCT03229187
  4. Details
NCT03229187 Clinical Trial

Specific Molecular Signatures Predict Neoadjuvant Chemotherapy Response in Cervical Cancer

Cervical Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03229187
Other study ID # 2016-NACT-01
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2016
Est. completion date September 30, 2020

Study information
Verified date June 2020
Source Huazhong University of Science and Technology
Contact Ma Ding, M.D.
Phone 86-27-8362681
Email dma@tjh.tjmu.edu.cn
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 240
Est. completion date September 30, 2020
Est. primary completion date September 30, 2020
Accepts healthy volunteers
Gender Female
Age group 18 Years to 70 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
China Tongji Hospital Wuhan Hubei

Sponsors (3)
Lead Sponsor Collaborator
Huazhong University of Science and Technology The Central Hospital of Wuhan, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary The clinical response to neoadjuvant chemotherapy clinical response(tumor size) 1 to 3 months
Secondary The pathological response to neoadjuvant chemotherapy pathological response(<3 mm or not) 1 to 3 months
See also
  Status Clinical Trial Phase
Recruiting NCT06223308 - A Study Evaluating the Safety and Efficacy of HB0028 in Subjects With Advanced Solid Tumors Phase 1/Phase 2
Terminated NCT03367871 - Combination Pembrolizumab, Chemotherapy and Bevacizumab in Patients With Cervical Cancer Phase 2
Active, not recruiting NCT04537156 - Efficacy, Immunogenicity and Safty Study of Recombinant Human Papillomavirus Vaccine(6,11,16,18,31,33,45,52,58 Type)(E.Coli) Phase 3
Recruiting NCT03668639 - Safety and Antiemetic Efficacy of Akynzeo Plus Dexamethasone During Radiotherapy and Concomitant Weekly Cisplatin Phase 2/Phase 3
Active, not recruiting NCT04242199 - Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099280 in Participants With Advanced Solid Tumors Phase 1
Withdrawn NCT04806945 - A Phase III Study to Evaluate Efficacy and Safety of First-Line Treatment With HLX10 + Chemotherapy in Patients With Advanced Cervical Cancer Phase 3
Active, not recruiting NCT04185389 - Long-Term Follow-Up of HPV FOCAL Participants
Withdrawn NCT03007771 - Magnetic Resonance-guided High-Intensity Focused Ultrasound (MR-HIFU) Used for Mild Hyperthermia Phase 1
Completed NCT03384511 - The Use of 18F-ALF-NOTA-PRGD2 PET/CT Scan to Predict the Efficacy and Adverse Events of Apatinib in Malignancies. Phase 4
Recruiting NCT05107674 - A Study of NX-1607 in Adults With Advanced Malignancies Phase 1
Completed NCT05120167 - Strategies for Endocervical Canal Investigation in Women With Abnormal Screening Cytology and Negative Colposcopy N/A
Recruiting NCT05483491 - KK-LC-1 TCR-T Cell Therapy for Gastric, Breast, Cervical, and Lung Cancer Phase 1
Recruiting NCT05736588 - Elimisha HPV (Human Papillomavirus) N/A
Completed NCT05862844 - Promise Women Project N/A
Recruiting NCT04934982 - Laparoscopic or Abdominal Radical Hysterectomy for Cervical Cancer(Stage IA1 With LVSI, IA2) N/A
Recruiting NCT03876860 - An Enhanced Vaginal Dilator to Reduce Radiation-Induced Vaginal Stenosis N/A
Completed NCT03652077 - A Safety and Tolerability Study of INCAGN02390 in Select Advanced Malignancies Phase 1
Completed NCT00543543 - Broad Spectrum HPV (Human Papillomavirus) Vaccine Study in 16-to 26-Year-Old Women (V503-001) Phase 3
Terminated NCT04864782 - QL1604 Plus Chemotherapy in Subjects With Stage IVB, Recurrent, or Metastatic Cervical Cancer Phase 2/Phase 3
Recruiting NCT04226313 - Self-sampling for Non-attenders to Cervical Cancer Screening N/A