Detection of Chlamydia DNA by Polymerase Chain Reaction in Primary Tubal and Ovarian Cancers Tissues : a Pilot Study

NCT02343510 | Completed DMC

• 1 other identifier: lab7682
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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 .

Conditions

Malignant Neoplasm of Fallopian Tube

Keywords

Fallopian tubal cancer, high grade serous , ovarian cancer

Outcome Measures

Primary Outcomes (1)

• Presence of chlamydia DNA in tubal and ovarian tissues

  Up to 24 weeks

Secondary Outcomes (1)

• Presence of concomitant tubal cancer with high grade serous ovarian cancer

  Up to 8 weeks

Study Arms (4)

primary tubal cancer group

Paraffin blocks of cases of primary tubal cancer

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

Other: PCR for chlamydia DNA in primary tubal cancer

Low Grade Serous Ovarian Cancer

Paraffin blocks of cases of low grade serous ovarian cancer

Other: PCR for chlamydia DNA in primary tubal cancer

normal tubes group

Paraffin blocks of tubes of hysterectomies due to non-oncologic causes

Other: PCR for chlamydia DNA in primary tubal cancer

Interventions

PCR for chlamydia DNA in primary tubal cancer OTHER

PCR for presence of chlamydia DNA in paraffin blocks retrieved for tubal and ovarian tissues in all groups

Low Grade Serous Ovarian Cancer; high grade serous ovarian cancer group; normal tubes group; primary tubal cancer group

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Pathology blocks of patients with primary tubal cancer and with high grade serous ovarian cancer and normal tubes.

You may qualify if:

• any patient with primary tubal cancer and high grade serous cancer and normal tubes.

You may not qualify if:

• clinical pelvic inflammatory disease
• salpingectomy for ectopic

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams Maternity Hospital

Cairo, Egypt

Location

Biospecimen

Retention: SAMPLES WITH DNA

Archival Paraffin blocks for cases of primary tubal cancers , high grade serous ovarian cancers , low grade serous ovarian cancers and normal Fallopian tubes removed during Hysterectomy operations for benign Gynecological indications

MeSH Terms

Conditions

Fallopian Tube Neoplasms; Ovarian Neoplasms

Interventions

Polymerase Chain Reaction

Condition Hierarchy (Ancestors)

Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Fallopian Tube Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Nucleic Acid Amplification Techniques; Genetic Techniques; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor mohammed laban

Study Record Dates

• First Submitted: January 10, 2015
• First Posted: January 22, 2015
• Study Start: January 1, 2015
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: July 18, 2017

Record last verified: 2017-07

Locations

EG (1)