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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| questionnaires survey | Diagnostic Test | 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 | Diagnostic Test | 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 | Diagnostic Test | Rectum dynamics testing consists of important parameters of rectum activities | ||
| ovarian reserve function | Diagnostic Test | Testing for ovarian reserve function consists of: Follicle-stimulating hormone Estradiol Anti-mullerian hormone Inhibin B |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Concentration of estradiol |
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Inclusion Criteria:
Exclusion Criteria:
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All the patients with primary cervical cancer in the future three years in Peking Union Medical College Hospital will be included in this study. They should be 18 years or older, accepting major therapy (including at least radical hysterectomy and/or radiotherapy) in the study cente and achieving response after the major therapy.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lei Li, M.D. | Contact | +8613911988831 | lileigh@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Lei Li, M.D. | Peking Union Medical College Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lei Li | Recruiting | Beijing | Beijing Municipality | 100730 | China |
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Peripheral blood samples for the testing of ovarian reserve function
Estradiol tested in peripheral blood
| Change from the baseline of four weeks before major therapy at following-up |
| 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 |
| Concentration of inhibin B | Inhibin B tested in peripheral blood | Change from the baseline of four weeks before major therapy at following-up |
| 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 |
| 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 |
| 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 |
| Maximun flow rate | Maximun flow rate tested by urodynamic testing | Change from the baseline of four weeks before major therapy at following-up |
| Average flow rate | Average flow rate tested by urodynamic testing | Change from the baseline of four weeks before major therapy at following-up |
| 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 |
| 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 |
| 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 |
| 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 |
| Residual urine volume | Residual urine volume tested by urodynamic testing | Change from the baseline of four weeks before major therapy at following-up |
| Anal sphincter pressure | Anal sphincter pressure tested by rectum dynamic testing | Change from the baseline of four weeks before major therapy at following-up |
| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| D059952 | Pelvic Floor Disorders |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D011248 | Pregnancy Complications |
| D052801 | Male Urogenital Diseases |
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