Comprehensive Study on the Quality of Life in Cervical Cancer Patients

NCT ID: NCT03967457

Last Updated: 2019-06-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

10000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-06-19

Study Completion Date

2023-06-01

Brief Summary

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This is prospective cohort study. All the patients with primary cervical cancer in the future three years in Peking Union Medical College Hospital will be included in this study. Before and after the major therapy (including at least radical hysterectomy and/or radiotherapy), the patients accept (1) the questionnaires survey about quality of life; (2) urodynamic testing; (3) rectum dynamics testing and (4) ovarian reserve function. The survival outcomes (disease-free survival and overall survival) will be supplemented as secondary objectives.

Detailed Description

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Conditions

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Quality of Life Cervical Cancer Urodynamics Rectum Dynamics Sex Dysfunction Pelvic Floor Disorders Ovarian Reserve Function Survivorship Disease-free Survival Overall Survival

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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questionnaires survey

Including four kinds of questionnaires: European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 (V3); EORTC QLQ-CX24; Eligibility Criteria (FSFI); and Short forms of two condition-specific quality-of-life questionnaires for women with pelvic floor disorders (PFIQ-7)

Intervention Type DIAGNOSTIC_TEST

Urodynamic testing

Urodynamic testing consists of important urodynamic parameters including:

Bladder capacity at the first void sense Bladder capacity at normal desire to void Bladder capacity at strong desire to void Qmax Qave Pves at Qmax Pdet at Qmax Cves at SDV Cdet at SDV Residual urine volume

Intervention Type DIAGNOSTIC_TEST

Rectum dynamics testing

Rectum dynamics testing consists of important parameters of rectum activities

Intervention Type DIAGNOSTIC_TEST

ovarian reserve function

Testing for ovarian reserve function consists of:

Follicle-stimulating hormone Estradiol Anti-mullerian hormone Inhibin B

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Primary uterine cervical carcinomas
* Aged 18 or older
* Accepting major therapy (including at least radical hysterectomy and/or radiotherapy) in the study center
* Informed consents delivered

* Not accepting any of the four kinds of evaluations for quality of life
* Recurrent patients
* Not achieving response after above major therapy
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Lei Li

OTHER

Sponsor Role lead

Responsible Party

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Lei Li

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Lei Li, M.D.

Role: PRINCIPAL_INVESTIGATOR

Peking Union Medical College Hospital

Locations

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Lei Li

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Lei Li, M.D.

Role: CONTACT

+8613911988831

Facility Contacts

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Lei Li, MD

Role: primary

008613911988831

Other Identifiers

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CCQOL

Identifier Type: -

Identifier Source: org_study_id

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