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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03967457
Other study ID # CCQOL
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 19, 2019
Est. completion date June 1, 2023

Study information

Verified date June 2019
Source Peking Union Medical College Hospital
Contact Lei Li, M.D.
Phone +8613911988831
Email lileigh@163.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 10000
Est. completion date June 1, 2023
Est. primary completion date June 1, 2022
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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


Intervention

Diagnostic Test:
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)
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
Rectum dynamics testing
Rectum dynamics testing consists of important parameters of rectum activities
ovarian reserve function
Testing for ovarian reserve function consists of: Follicle-stimulating hormone Estradiol Anti-mullerian hormone Inhibin B

Locations

Country Name City State
China Lei Li Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Lei Li

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Scores from EORTC QLQ-C30 Scores calculated from European Organization for Research and Treatment of Cancer (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.
Primary Scores from EORTC QLQ-CX24 Scores calculated 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.
Secondary Concentration of follicle-stimulating hormone Follicle-stimulating hormone tested in peripheral blood Change from the baseline of four weeks before major therapy at following-up
Secondary Concentration of estradiol Estradiol tested in peripheral blood Change from the baseline of four weeks before major therapy at following-up
Secondary Concentration of anti-mullerian hormone Anti-mullerian hormone tested in peripheral blood Change from the baseline of four weeks before major therapy at following-up
Secondary Concentration of inhibin B Inhibin B tested in peripheral blood Change from the baseline of four weeks before major therapy at following-up
Secondary Bladder capacity at the first void sense Bladder capacity at the first void sense tested by urodynamic testing Change from the baseline of four weeks before major therapy at following-up
Secondary Bladder capacity at normal desire to void Bladder capacity at normal desire to void tested by urodynamic testing Change from the baseline of four weeks before major therapy at following-up
Secondary Bladder capacity at strong desire to void Bladder capacity at strong desire to void tested by urodynamic testing Change from the baseline of four weeks before major therapy at following-up
Secondary Maximun flow rate Maximun flow rate tested by urodynamic testing Change from the baseline of four weeks before major therapy at following-up
Secondary Average flow rate Average flow rate tested by urodynamic testing Change from the baseline of four weeks before major therapy at following-up
Secondary Bladder pressure at maximun flow rate Bladder pressure at maximun flow rate tested by urodynamic testing Change from the baseline of four weeks before major therapy at following-up
Secondary Detrusor pressure at maximun flow rate Detrusor pressure at maximun flow rate tested by urodynamic testing Change from the baseline of four weeks before major therapy at following-up
Secondary Bladder compliance at strong desire to void Bladder compliance at strong desire to void tested by urodynamic testing Change from the baseline of four weeks before major therapy at following-up
Secondary Detrusor compliance at strong desire to void Detrusor compliance at strong desire to void tested by urodynamic testing Change from the baseline of four weeks before major therapy at following-up
Secondary Residual urine volume Residual urine volume tested by urodynamic testing Change from the baseline of four weeks before major therapy at following-up
Secondary Anal sphincter pressure Anal sphincter pressure tested by rectum dynamic testing Change from the baseline of four weeks before major therapy at following-up
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