- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07385976
The Role of Blood Perfusion in Cervical Cancer, Cervical Intraepithelial Neoplasm and Ovarian Cancer Patients
Study Overview
Status
Intervention / Treatment
Detailed Description
Patients and methods:
Women with cervical cancer, cervical intraepithelial neoplasm, ovarian cancer, or the control will be invited to particilate in this study.Then, 3D power Doppler Ultrasound will be performed to capture (1) the cervical volume, vascularity and blood perfusion, and (2) ovarian tumor vascularity and blood perfusion. The sonographic data will be correlated to clinical and pathological data.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
-
-
-
New Taipei City, Taiwan, 220
- Far Eastern Memorial Hospital
-
Contact:
- Sheng-Mou Hsiao, MD
- Phone Number: 1818 +886-2-89667000
- Email: smhsiao2@gmail.com
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-
Banqiao
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New Taipei City, Banqiao, Taiwan, 22050
- Department of Obstetrics and Gynecology, Far Eastern Memorial Hospital,
-
Contact:
- Sheng-Mou Hsiao, MD
- Phone Number: 1818 +886-2-89667000
- Email: smhsiao2@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
Regarding the topic "Hemoperfusion characteristics of cervical cancer and precancerous lesions, and the correlation between hemoperfusion and prognosis":
- Adult women who have had a normal cervical smear within the past three years and have no other gynecological cancers (control group).
- Adult women with cervical cancer or precancerous lesions.
Regarding the topic "Correlation between hemoperfusion and prognosis of ovarian cancer":
- Adult women suspected of having ovarian cancer, fallopian tube cancer, or peritoneal cancer before surgery.
Exclusion Criteria:
Regarding the topic "Hemoperfusion characteristics of cervical cancer and precancerous lesions of the cervix, and the correlation between hemoperfusion and prognosis":
1. Patients who cannot cooperate with vaginal 3D ultrasound scans.
Regarding the topic "Correlation between hemoperfusion and prognosis of ovarian cancer":
- Patients who cannot cooperate with vaginal or abdominal 3D ultrasound scans.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
cervical cancer
cervical cancer patients
|
3D doppler ultrasound to measure VI, FI, VFI.
|
|
cervical intraepithelial neoplasm
cervical intraepithelial neoplasm patients
|
3D doppler ultrasound to measure VI, FI, VFI.
|
|
control
Gynecological patients without cervical disease
|
3D doppler ultrasound to measure VI, FI, VFI.
|
|
ovarian cancer
ovarian cancer patients
|
3D doppler ultrasound to measure VI, FI, VFI.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Vascularization-flow index
Time Frame: 3 years
|
|
3 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Vascularization index
Time Frame: 3 years
|
1. Compare the vascularization index values between cervical cancer, cervical intraepithelial neoplasia and the control group.
2. To assess whether vascularization index is a predictor of progression-free survival in women with ovarian cancer
|
3 years
|
|
Flow index
Time Frame: 3 years
|
1. Compare the flow index values between cervical cancer, cervical intraepithelial neoplasia and the control group.
2. To assess whether flow index is a predictor of progression-free survival in women with ovarian cancer
|
3 years
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Genital Diseases
- Endocrine System Diseases
- Urogenital Neoplasms
- Neoplasms by Site
- Neoplasms
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Uterine Diseases
- Genital Diseases, Female
- Endocrine Gland Neoplasms
- Ovarian Diseases
- Adnexal Diseases
- Genital Neoplasms, Female
- Gonadal Disorders
- Precancerous Conditions
- Uterine Cervical Diseases
- Uterine Neoplasms
- Ovarian Neoplasms
- Uterine Cervical Neoplasms
- Uterine Cervical Dysplasia
- Diagnostic Techniques and Procedures
- Diagnosis
- Diagnostic Imaging
- Ultrasonography
- Ultrasonography, Doppler
Other Study ID Numbers
- 114237-F
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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