Cervical Cancer, Disease-free Survival, Ovarian Reserve Function, Overall Survival, Pelvic Floor Disorders, Quality of Life, Rectum Dynamics, Sex Dysfunction, Survivorship, Urodynamics
Conditions
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.
Interventions
DIAGNOSTIC_TESTquestionnaires 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)
DIAGNOSTIC_TESTUrodynamic 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
DIAGNOSTIC_TESTRectum dynamics testing
Rectum dynamics testing consists of important parameters of rectum activities
DIAGNOSTIC_TESTovarian reserve function
Testing for ovarian reserve function consists of: Follicle-stimulating hormone Estradiol Anti-mullerian hormone Inhibin B
Sponsors
Lei Li
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Concentration of inhibin B | Change from the baseline of four weeks before major therapy at following-up | Inhibin B 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 |
| 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 |
| Maximun flow rate | Change from the baseline of four weeks before major therapy at following-up | Maximun flow rate tested by urodynamic testing |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Residual urine volume | Change from the baseline of four weeks before major therapy at following-up | Residual urine volume 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 |
| Average flow rate | Change from the baseline of four weeks before major therapy at following-up | Average flow rate tested by urodynamic testing |
| Concentration of estradiol | Change from the baseline of four weeks before major therapy at following-up | Estradiol tested in peripheral blood |
Countries
China
Contacts
Primary ContactLei Li, M.D.
Outcome results
None listed