Malignant Neoplasm of Fallopian TubeNCT02343510
Detection of Chlamydia DNA by Polymerase Chain Reaction in Primary Tubal and Ovarian Cancers Tissues : a Pilot Study
An observational study of Malignant Neoplasm of Fallopian Tube, run by Ain Shams University at 1 site in Egypt.
Trial summary
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 . Read more about this study
- Who is it for?
- Ages 40 to 80 years, women only
- Conditions the study is for
- Malignant Neoplasm of Fallopian Tube
- What is being tested?
- PCR for chlamydia DNA in primary tubal cancer
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2015to Mar 2017
- 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 40 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Pathology blocks of patients with primary tubal cancer and with high grade serous ovarian cancer and normal tubes.
Who may be able to join
- any patient with primary tubal cancer and high grade serous cancer and normal tubes.
Who cannot join
- clinical pelvic inflammatory disease
- salpingectomy for ectopic
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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 .
Read the 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 .
- Conditions
- Malignant Neoplasm of Fallopian Tube
- Being tested
- PCR for chlamydia DNA in primary tubal cancer
- Keywords
- Fallopian tubal cancer, high grade serous , ovarian cancer
- Medical subject headings
- Fallopian Tube Neoplasms, Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCR for chlamydia DNA in primary tubal cancerOther
PCR for presence of chlamydia DNA in paraffin blocks retrieved for tubal and ovarian tissues in all groups
| Study group | Role | What they receive |
|---|---|---|
| primary tubal cancer group | Paraffin blocks of cases of primary tubal cancer Receives: Other: PCR for chlamydia DNA in primary tubal cancer | |
| high grade serous ovarian cancer group | Paraffin blocks of cases of high grade serous ovarian cancer Receives: Other: PCR for chlamydia DNA in primary tubal cancer | |
| Low Grade Serous Ovarian Cancer | Paraffin blocks of cases of low grade serous ovarian cancer Receives: Other: PCR for chlamydia DNA in primary tubal cancer | |
| normal tubes group | Paraffin blocks of tubes of hysterectomies due to non-oncologic causes Receives: Other: PCR for chlamydia DNA in primary tubal cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of chlamydia DNA in tubal and ovarian tissues
Measured: Up to 24 weeks
Secondary outcomes (1)
Presence of concomitant tubal cancer with high grade serous ovarian cancer
Measured: Up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2015 (estimated)
- Study startJan 2015
- Primary completionMar 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Neoplasm of Fallopian TubeStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, dr mohamed laban, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02343510
- Sponsor's protocol ID
- lab7682
- Status last verified
- Jul 2017
- First submitted
- 10 Jan 2015
- Last updated
- 18 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Chlamydia DNA by Polymerase Chain Reaction ( PCR ) in Tumours Tissue of Primary Tubal and Ovarian Cancers : a Pilot Study
- ClinicalTrials.gov ID
- NCT02343510
- Acronym / sponsor ID
- lab7682
- Conditions
- Malignant Neoplasm of Fallopian Tube
- Keywords
- Fallopian tubal cancer, high grade serous , ovarian cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 22 Jan 2015 (estimated)
- 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.
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 .
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| primary tubal cancer group | – | Other: PCR for chlamydia DNA in primary tubal cancerParaffin blocks of cases of primary tubal cancer |
| high grade serous ovarian cancer group | – | Other: PCR for chlamydia DNA in primary tubal cancerParaffin blocks of cases of high grade serous ovarian cancer |
| Low Grade Serous Ovarian Cancer | – | Other: PCR for chlamydia DNA in primary tubal cancerParaffin blocks of cases of low grade serous ovarian cancer |
| normal tubes group | – | Other: PCR for chlamydia DNA in primary tubal cancerParaffin blocks of tubes of hysterectomies due to non-oncologic causes |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pathology blocks of patients with primary tubal cancer and with high grade serous ovarian cancer and normal tubes.
Key inclusion criteria (1 listed)
- any patient with primary tubal cancer and high grade serous cancer and normal tubes.
Key exclusion criteria (2 listed)
- clinical pelvic inflammatory disease
- salpingectomy for ectopic
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 |
|---|---|---|
| PCR for chlamydia DNA in primary tubal cancerPCR for presence of chlamydia DNA in paraffin blocks retrieved for tubal and ovarian tissues in all groups | Other | Low Grade Serous Ovarian Cancer, high grade serous ovarian cancer group, normal tubes group, primary tubal cancer group |
Primary outcome
Presence of chlamydia DNA in tubal and ovarian tissues
Time frame: Up to 24 weeks
1 secondary outcome
Presence of concomitant tubal cancer with high grade serous ovarian cancer
Time frame: Up to 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Malignant Neoplasm of Fallopian Tube, run by Ain Shams University at 1 site in Egypt.
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 1 inclusion and 2 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: finished, as of the sponsor's last update on 18 Jul 2017. 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 Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of chlamydia DNA in tubal and ovarian tissues (time frame: Up to 24 weeks). 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 18 Jul 2017; AzTrials last refreshed its copy on 7 Nov 2026.