The Effect of Postoperative Therapy on the Quality of Lif... | NCT02018003

Studies
The Effect of Postoperative Therapy on the Quality of Life of Patients With Early Cervical Cancer Research

NCT02018003

Sponsor

Peking University

Status

Unknown status

Last Update Posted

Dec 23, 2013Estimated

Enrollment

180Estimated

Phase

Not provided

Conditions

Uterine Cervical Neoplasms

Interventions

Not provided

Countries

Not provided

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

Nov 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2014

Primary Completion Date

Oct 2016Estimated

Completion Date

Dec 2016Estimated

First Submitted Date

Dec 17, 2013

First Submission Date that Met QC Criteria

Dec 20, 2013

First Posted Date

Dec 23, 2013Estimated

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

Dec 20, 2013

Last Update Posted Date

Dec 23, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Yunong Gao, the head of department of gynecological oncology, Peking UniversityPrincipal Investigator

Lead Sponsor

Peking UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to assess the women's quality of life, who accepted chemotherapy,radiotherapy, concurrent radiochemotherapy or who didn't accept therapy, after operation.

Detailed Description

The study projects to follow up 180-200 early stage cervical cancer patients after operation and assess the women's quality of life by the scales: ECOG, Functional Assessment of Cancer Therapy, EuroQol-5 Dimensions, and Kupperman index.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

180Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Quality of life for the women with early stage cervical cancer who underwent operation		up to 12 months after operation

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

≮ 18 years, cervical cancer verified by pathology，
- IIA stage, accepted the operation ( Piver III and pelvic lymph node dissection) as initial therapy， obtained the patient's agreement

Exclusion Criteria:

the patient had accepted chemotherapy or radiotherapy before operation

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

The women with early stage cervical cancer, who underwent operation in Peking University School of Oncology.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Gao Weijiao	Contact	86-10-88196102		gaoweijiao@126.com

Overall Officials

Name	Affiliation	Role
Gao Yunong	Peking University	Study Director

Locations

Not provided

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