Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

All Conditions

Infections

Rare Diseases

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Chlamydia Infections

Fallopian Tube Neoplasms

Carcinoma

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Fallopian Tube Diseases

Ovarian Cancer

Ovarian Epithelial Cancer

Fallopian Tube Cancer

Paraffin blocks of cases of primary tubal cancer

Paraffin blocks of cases of high grade serous ovarian cancer

Paraffin blocks of cases of low grade serous ovarian cancer

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

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

PCR for chlamydia DNA in primary tubal cancer

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 .

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 .

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

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

Detection of Chlamydia DNA by Polymerase Chain Reaction ( PCR ) in Tumours Tissue of Primary Tubal and Ovarian Cancers : a Pilot Study

Ain Shams University

professor mohammed laban

Digestive System Diseases

Peritoneal Neoplasms

Abdominal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Peritoneal Diseases

All patients will undergo a diagnostic laparoscopic assessment of disease following neoadjuvant chemotherapy

The patient will initially undergo a diagnostic laparoscopy by a minimally invasive approach and entry method. The decision of which approach and entry to perform will be dictated by the primary surgeon of record's preference and their assessment of pre-operative patient factors. Once the primary surgeon determines the areas of macroscopic disease, he/she will make an assessment as to the need to convert to a laparotomy or continue laparoscopically. At the completion of the procedure, it will be noted whether an optimal cytoreduction (≤ 1 cm residual disease) or a sub-optimal cytoreduction (\>1 cm residual disease) was performed.

Diagnostic laparoscopy

Chad Michener, MD

The purpose of this study is to see if patients undergoing a laparoscopic surgery for removal of ovarian, fallopian tube, or primary peritoneal cancer following neoadjuvant chemotherapy (neoadjuvant- chemotherapy given before surgery) is feasible, safe, and provides similar outcomes as compared to undergoing a large abdominal incision. Minimally invasive, or laparoscopic, surgery is a type of surgery where only small incisions are made on the abdomen and surgical instruments are placed through these incisions to perform the surgery. This type of surgery has been shown to improve outcomes in many types of surgery, including in gynecologic cancer surgery. Specifically, researchers know that patients who have minimally invasive surgery have less pain after surgery, can go home quicker from the hospital, healing time is more rapid, and potentially this can translate into returning to chemotherapy sooner. Specifically, in ovarian, fallopian tube, and primary peritoneal cancer, minimally invasive surgery has not been used as much because these cancers can have tumors all throughout the inside of the abdomen (i.e. wide tumor burden) and located in areas that are sometimes not easily reachable with laparoscopic instruments. However, the reason patients receive neoadjuvant chemotherapy is to shrink the tumor/s to make the surgery less extensive and the recovery easier. It is unknown if minimally invasive surgery can be used in this setting and by studying this, the study team will be able to determine if patient outcomes are improved by implementing (using) this surgical technique.

The objective of this study is to implement, evaluate, and further investigate the role of minimally invasive surgery in patients undergoing interval debulking following neoadjuvant chemotherapy in patients with advanced ovarian cancer.

Primary Objective:

Prospectively evaluate the feasibility and safety of the minimally invasive interval debulking approach

Secondary Objective(s)

1. Identify the patient population for which the minimally invasive interval debulking approach will offer comparable, if not improved, outcomes as the laparotomic interval debulking technique
2. Validate previously identified preoperative imaging computed tomography (CT) criteria and CA-125 values to predict optimal cytoreduction in laparotomic primary cytoreductive surgery and apply it towards the prediction of optimal cytoreduction (≤ 1 cm residual disease) following minimally invasive interval debulking surgery
3. Validate the previously identified laparoscopic scoring system for primary cytoreductive surgery and apply it towards the prediction of optimal cytoreduction (≤ 1 cm residual disease) following minimally invasive interval debulking surgery
4. Monitor the number of hospital days in the first 30 days postoperatively (length of stay after interval debulking including any days of readmission)
5. Evaluate the oncologic safety as it relates to time to return to chemotherapy in patients who undergo laparoscopic minimally invasive interval debulking surgery
6. Evaluate the complications as assessed by incidence of a composite of major complications and a second composite of minor complications

Study Design This will be a prospective pilot study to address feasibility and safety to identify a patient population amenable to this surgical approach. This will allow for the future trial to include randomization

Debulking Surgery in Ovarian Cancer

Minimally Invasive Interval Debulking Surgery in Ovarian Cancer

Accordion Severity Grading system with grade 3-4 scores. Grade 3 and 4 are severe complications or death. Severe complications are those requiring endoscopic or interventional radiologic procedures or re-operation as well as complications resulting in failure of 1 or more organ system. If fewer than 14% of patients have grade 3 or 4 complications, the surgery will be deemed safe.

Rate of optimal resection after interval debulking surgery is expected to be between 73%-81%

If greater than 13 of the 50 patients planned to be enrolled on the study complete the laparoscopic surgery, the study will be deemed feasible

Time from the end of surgery to when the patient is discharged

From the time of surgery to when the patient returns to chemotherapy treatments. Shorter times between surgery and chemotherapy are positive outcomes

23 point index where higher scores indicate poorer outcomes

17 point index where higher scores indicate poorer outcomes

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Detection of Chlamydia DNA by Polymerase Chain Reaction in Primary Tubal and Ovarian Cancers Tissues : a Pilot Study	NCT02343510	Malignant Neopl...	PCR for chlamyd...	40 Years - 80 Years	Ain Shams University
Debulking Surgery in Ovarian Cancer	NCT03378128	Malignant Neopl... Malignant Neopl... Malignant Neopl...	Diagnostic lapa...	19 Years -	Case Comprehensive Cancer Center

Spots Global Cancer Trial Database for malignant neoplasm of fallopian tube