- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02343510
Detection of Chlamydia DNA by Polymerase Chain Reaction in Primary Tubal and Ovarian Cancers Tissues : a Pilot Study
July 16, 2017 updated by: dr mohamed laban, Ain Shams University
Detection of Chlamydia DNA by Polymerase Chain Reaction ( PCR ) in Tumours Tissue of Primary Tubal and Ovarian Cancers : a Pilot Study
PCR for chlamydia DNA is done in paraffin blocks of cases of primary tubal cancer and is compared to cases of high grade serous ovarian cancer and normal tubes .
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The investigators shall review the early cancer detection unite pathology records for the past 10 years , for cases diagnosed with primary Fallopian tube cancers , cases of high and low grade serous ovarian cancer and cases underwent hysterectomy and salpingectomy for non oncological reasons.
Paraffin blocks for suitable selected patients will be examined histologically to confirm the primary diagnosis .
Chlamydia DNA in these paraffin blocks of the Fallopian tubes and ovarian tissues will be examined using PCR techniques .
The possible correlation between the presence of Chlamydia DNA and the ovarian serous tumours and primary tubal cancer will be analyzed statistically .
Study Type
Observational
Enrollment (Actual)
70
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Cairo, Egypt
- Ain Shams Maternity Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Probability Sample
Study Population
Pathology blocks of patients with primary tubal cancer and with high grade serous ovarian cancer and normal tubes.
Description
Inclusion Criteria:
- any patient with primary tubal cancer and high grade serous cancer and normal tubes.
Exclusion Criteria:
- clinical pelvic inflammatory disease
- salpingectomy for ectopic
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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primary tubal cancer group
Paraffin blocks of cases of primary tubal cancer
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PCR for presence of chlamydia DNA in paraffin blocks retrieved for tubal and ovarian tissues in all groups
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high grade serous ovarian cancer group
Paraffin blocks of cases of high grade serous ovarian cancer
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PCR for presence of chlamydia DNA in paraffin blocks retrieved for tubal and ovarian tissues in all groups
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Low Grade Serous Ovarian Cancer
Paraffin blocks of cases of low grade serous ovarian cancer
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PCR for presence of chlamydia DNA in paraffin blocks retrieved for tubal and ovarian tissues in all groups
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normal tubes group
Paraffin blocks of tubes of hysterectomies due to non-oncologic causes
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PCR for presence of chlamydia DNA in paraffin blocks retrieved for tubal and ovarian tissues in all groups
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Presence of chlamydia DNA in tubal and ovarian tissues
Time Frame: Up to 24 weeks
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Up to 24 weeks
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Presence of concomitant tubal cancer with high grade serous ovarian cancer
Time Frame: Up to 8 weeks
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Up to 8 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2015
Primary Completion (Actual)
March 1, 2017
Study Completion (Actual)
March 1, 2017
Study Registration Dates
First Submitted
January 10, 2015
First Submitted That Met QC Criteria
January 21, 2015
First Posted (Estimate)
January 22, 2015
Study Record Updates
Last Update Posted (Actual)
July 18, 2017
Last Update Submitted That Met QC Criteria
July 16, 2017
Last Verified
July 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Urogenital Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Genital Neoplasms, Female
- Endocrine System Diseases
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Endocrine Gland Neoplasms
- Fallopian Tube Diseases
- Neoplasms
- Ovarian Neoplasms
- Fallopian Tube Neoplasms
- Carcinoma, Ovarian Epithelial
Other Study ID Numbers
- lab7682
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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