Specific Molecular Signatures Predict Neoadjuvant Chemoth... | NCT03229187

Studies
Specific Molecular Signatures Predict Neoadjuvant Chemotherapy Response in Cervical Cancer

NCT03229187

Sponsor

Huazhong University of Science and Technology

Status

Unknown status

Last Update Posted

Jun 16, 2020Actual

Enrollment

240Estimated

Phase

Not provided

Conditions

Uterine Cervical Neoplasms
Cervical Cancer
Uterine Cervical Cancer

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2016Actual

Primary Completion Date

Sep 30, 2020Estimated

Completion Date

Sep 30, 2020Estimated

First Submitted Date

Jul 20, 2017

First Submission Date that Met QC Criteria

Jul 24, 2017

First Posted Date

Jul 25, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 11, 2020

Last Update Posted Date

Jun 16, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ding Ma, Director of Department of Gynecology and Obstetrics, Huazhong University of Science and TechnologyPrincipal Investigator

Lead Sponsor

Huazhong University of Science and TechnologyOTHER

Collaborators

Name	Class
Zhejiang University	OTHER
Wuhan Central Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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 specific molecular signatures to predict the effects of neoadjuvant chemotherapy.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

5 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

240Estimated

Label	Type	Description	Intervention Names
neoadjuvant chemotherapy

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Not provided

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ma Ding, M.D.	Contact	86-27-8362681		dma@tjh.tjmu.edu.cn

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tongji Hospital	Recruiting	Wuhan	Hubei	430030	China

Condition Browse Module

MeSH Terms

ID	Term
D002583	Uterine Cervical Neoplasms

Ancestor Terms

ID	Term
D014594	Uterine Neoplasms
D005833	Genital Neoplasms, Female
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site

Browse Leaves

Not provided

Browse Branches

Not provided