Comprehensive Study on the Quality of Life in Cervical Cancer Patients

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

• Registration Number: NCT03967457
• Lead Sponsor: Lei Li

Brief Summary

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

Not available

Study Timeline

• Study First Submitted: 2019-05-23
• Study First Submitted QC: 2019-05-24
• Study First Posted: 2019-05-30
• Status Verified: 2019-06
• Study Start: 2019-06-19
• Last Update Submitted: 2019-06-19
• Last Update Posted: 2019-06-20
• Primary Completion: 2022-06-01
• Study Completion: 2023-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 10000

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

Exclusion Criteria

• Not meeting any of the inclusion criteria
• Not accepting any of the four kinds of evaluations for quality of life
• Recurrent patients
• Not achieving response after above major therapy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Scores from EORTC QLQ-C30	Change from the baseline of four weeks before major therapy at following-up. The standard scores ranges from 0 to 100, and the higher score, the more inferior quality of life.	Scores calculated from European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30
Scores from EORTC QLQ-CX24	Change from the baseline of four weeks before major therapy at following-up. The standard scores ranges from 0 to 100, and the higher score, the more inferior quality of life.	Scores calculated from EORTC QLQ-CX24

Secondary Outcome Measures

Name	Time	Method
Concentration of follicle-stimulating hormone	Change from the baseline of four weeks before major therapy at following-up	Follicle-stimulating hormone tested in peripheral blood
Concentration of estradiol	Change from the baseline of four weeks before major therapy at following-up	Estradiol tested in peripheral blood
Bladder capacity at the first void sense	Change from the baseline of four weeks before major therapy at following-up	Bladder capacity at the first void sense tested by urodynamic testing
Concentration of anti-mullerian hormone	Change from the baseline of four weeks before major therapy at following-up	Anti-mullerian hormone tested in peripheral blood
Residual urine volume	Change from the baseline of four weeks before major therapy at following-up	Residual urine volume tested by urodynamic testing
Average flow rate	Change from the baseline of four weeks before major therapy at following-up	Average flow rate tested by urodynamic testing
Bladder pressure at maximun flow rate	Change from the baseline of four weeks before major therapy at following-up	Bladder pressure at maximun flow rate tested by urodynamic testing
Bladder compliance at strong desire to void	Change from the baseline of four weeks before major therapy at following-up	Bladder compliance at strong desire to void tested by urodynamic testing
Concentration of inhibin B	Change from the baseline of four weeks before major therapy at following-up	Inhibin B tested in peripheral blood
Maximun flow rate	Change from the baseline of four weeks before major therapy at following-up	Maximun flow rate tested by urodynamic testing
Bladder capacity at normal desire to void	Change from the baseline of four weeks before major therapy at following-up	Bladder capacity at normal desire to void tested by urodynamic testing
Bladder capacity at strong desire to void	Change from the baseline of four weeks before major therapy at following-up	Bladder capacity at strong desire to void tested by urodynamic testing
Detrusor pressure at maximun flow rate	Change from the baseline of four weeks before major therapy at following-up	Detrusor pressure at maximun flow rate tested by urodynamic testing
Detrusor compliance at strong desire to void	Change from the baseline of four weeks before major therapy at following-up	Detrusor compliance at strong desire to void tested by urodynamic testing
Anal sphincter pressure	Change from the baseline of four weeks before major therapy at following-up	Anal sphincter pressure tested by rectum dynamic testing

Trial Locations

Locations (1)

Lei Li; 🇨🇳 Beijing, Beijing, China