Quality of LifeNCT03967457
Comprehensive Study on the Quality of Life in Cervical Cancer Patients
An observational study of Quality of Life and Cervical Cancer, run by Lei Li at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Quality of Life, Cervical Cancer, Urodynamics
- What is being tested?
- questionnaires survey, Urodynamic testing and Rectum dynamics testing
- How many people
- 10,000 participants
- Where
- 1 siteChina
- Study dates
- 19 Jun 2019to 1 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Lei Li
Beijing, Beijing Municipality, 100730
Lei Li, MD, 008613911988831, lileigh@163.com
About this study
Official title: Comprehensive Study on the Quality of Life in Cervical Cancer Patients: A Prospective Cohort Study
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.
- Conditions
- Quality of Life, Cervical Cancer, Urodynamics, Rectum Dynamics, Sex Dysfunction, Pelvic Floor Disorders
- Being tested
- questionnaires survey, Urodynamic testing, Rectum dynamics testing, ovarian reserve function
- Medical subject headings
- Uterine Cervical Neoplasms, Pelvic Floor Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaires surveyDiagnostic 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 testingDiagnostic 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 testingDiagnostic test
Rectum dynamics testing consists of important parameters of rectum activities
ovarian reserve functionDiagnostic test
Testing for ovarian reserve function consists of:
Follicle-stimulating hormone Estradiol Anti-mullerian hormone Inhibin B
What is being measured
The primary outcome is the main question the study is designed to answer.
Scores from EORTC QLQ-C30
Scores calculated from European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30
Measured: 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
Measured: 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 outcomes (15)
Concentration of follicle-stimulating hormone
Follicle-stimulating hormone tested in peripheral blood
Measured: Change from the baseline of four weeks before major therapy at following-up
Concentration of estradiol
Estradiol tested in peripheral blood
Measured: 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
Measured: Change from the baseline of four weeks before major therapy at following-up
Concentration of inhibin B
Inhibin B tested in peripheral blood
Measured: 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
Measured: 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
Measured: 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
Measured: Change from the baseline of four weeks before major therapy at following-up
Maximun flow rate
Maximun flow rate tested by urodynamic testing
Measured: Change from the baseline of four weeks before major therapy at following-up
Average flow rate
Average flow rate tested by urodynamic testing
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Change from the baseline of four weeks before major therapy at following-up
Residual urine volume
Residual urine volume tested by urodynamic testing
Measured: Change from the baseline of four weeks before major therapy at following-up
Anal sphincter pressure
Anal sphincter pressure tested by rectum dynamic testing
Measured: Change from the baseline of four weeks before major therapy at following-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2019
- Study start19 Jun 2019
- Primary completion1 Jun 2022 (estimated)
- Study completion1 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lei Li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lei Li, Peking Union Medical College Hospital
- Investigators
- Lei Li, M.D., Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03967457
- Sponsor's protocol ID
- CCQOL
- Status last verified
- Jun 2019
- First submitted
- 23 May 2019
- Last updated
- 20 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Study on the Quality of Life in Cervical Cancer Patients: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT03967457
- Acronym / sponsor ID
- CCQOL
- Conditions
- Quality of Life, Cervical Cancer, Urodynamics, Rectum Dynamics, Sex Dysfunction, Pelvic Floor Disorders
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Lei LiUniversity, hospital or other
- Study start
- 19 Jun 2019 (actual)
- Primary completion
- 1 Jun 2022 (estimated)
- Study completion
- 1 Jun 2023 (estimated)
- First posted
- 30 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| questionnaires surveyIncluding 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 test | – |
| Urodynamic testingUrodynamic 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 test | – |
| Rectum dynamics testingRectum dynamics testing consists of important parameters of rectum activities | Diagnostic test | – |
| ovarian reserve functionTesting for ovarian reserve function consists of: Follicle-stimulating hormone Estradiol Anti-mullerian hormone Inhibin B | Diagnostic test | – |
Primary outcome
Scores from EORTC QLQ-C30
Time frame: 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
Time frame: 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
15 secondary outcomes
Concentration of follicle-stimulating hormone
Time frame: Change from the baseline of four weeks before major therapy at following-up
Concentration of estradiol
Time frame: Change from the baseline of four weeks before major therapy at following-up
Concentration of anti-mullerian hormone
Time frame: Change from the baseline of four weeks before major therapy at following-up
Concentration of inhibin B
Time frame: Change from the baseline of four weeks before major therapy at following-up
Bladder capacity at the first void sense
Time frame: Change from the baseline of four weeks before major therapy at following-up
Bladder capacity at normal desire to void
Time frame: Change from the baseline of four weeks before major therapy at following-up
Bladder capacity at strong desire to void
Time frame: Change from the baseline of four weeks before major therapy at following-up
Maximun flow rate
Time frame: Change from the baseline of four weeks before major therapy at following-up
Average flow rate
Time frame: Change from the baseline of four weeks before major therapy at following-up
Bladder pressure at maximun flow rate
Time frame: Change from the baseline of four weeks before major therapy at following-up
Detrusor pressure at maximun flow rate
Time frame: Change from the baseline of four weeks before major therapy at following-up
Bladder compliance at strong desire to void
Time frame: Change from the baseline of four weeks before major therapy at following-up
Detrusor compliance at strong desire to void
Time frame: Change from the baseline of four weeks before major therapy at following-up
Residual urine volume
Time frame: Change from the baseline of four weeks before major therapy at following-up
Anal sphincter pressure
Time frame: Change from the baseline of four weeks before major therapy at following-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lei Li, M.D. principal investigator
Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Quality of Life and Cervical Cancer, run by Lei Li at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lei Li, M.D. (+8613911988831, lileigh@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Scores from EORTC QLQ-C30 (time frame: 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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2019.