Evaluation of Surgical Excision of Cardiophrenic Lymph No... | NCT03235648

Studies
Evaluation of Surgical Excision of Cardiophrenic Lymph Nodes in Patients With Advanced Ovarian Cancer

NCT03235648

Sponsor

Mansoura University

Status

Unknown status

Last Update Posted

Aug 1, 2017Actual

Enrollment

25Estimated

Phase

Not Applicable

Conditions

Ovarian Cancer

Interventions

cardiophrenic lymph nodes resection

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2017Actual

Primary Completion Date

Jun 1, 2019Estimated

Completion Date

Jun 1, 2023Estimated

First Submitted Date

Jul 2, 2017

First Submission Date that Met QC Criteria

Jul 30, 2017

First Posted Date

Aug 1, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 30, 2017

Last Update Posted Date

Aug 1, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Evaluation of surgical excision of cardiophrenic lymph nodes in patients with advanced ovarian cancer

Detailed Description

The role of cardiophrenic lymph node assessment and excision in advanced ovarian cancer is still debatable , correlation of radiological finding with pathological findings after reaction of radiological positive lymph nodes and its impact in diseases free survival and over all survival

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

25Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
cardiophrenic nodes excision in ovarian cancer	Experimental	We are going to evaluate the comorbidites and impact of cardiophrenic lymph nodes excision in cases of advanced ovarian cancer with positive cardiophrenic lymph nodes	Procedure: cardiophrenic lymph nodes resection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
cardiophrenic lymph nodes resection	Procedure	surgical resection	cardiophrenic nodes excision in ovarian cancer

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
number of CPN retrieved/pathological nodes	correlation of radiological active lymph nodes with pathological findings	up to 3 years

Secondary Outcomes

Measure	Description	Time Frame
Progression free survival	2 years progression without disease recurrence	up to 2 years following the end of study

Other Outcomes

Measure	Description	Time Frame
Overall survival	2 years survivals of the patients	up to 2 years following the end of study

Eligibility Module

Eligibility Criteria

Inclusion criteria

Ovarian cancer patient (FIGO stage III-IV)
Preoperative CT showing CPLN with short axis diameter > 5mm.
Anathestically fit patient (ASA score I or II).
Accepted pulmonary function test.
Patient who received neoadjuvant chemotherapy or recurrent cases may be enrolled
Written informed consent.
Achievement of optimal cytoreduction intra-abdominal( No residual disease more than 1 cm )

Exclusion Criteria:

Anathestically unfit patient
Unresectable disease
Patient refusal
No detected CPLN by preoperative radiology

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Basel R. Abdelfattah, MD, MRCS	Contact	01001974340	+2	dr.basel@hotmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Oncology center, Mansoura University	Recruiting	Cairo	Dakhlia	35116	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010051	Ovarian Neoplasms

Ancestor Terms

ID	Term
D004701	Endocrine Gland Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D010049	Ovarian Diseases

Browse Leaves

Not provided

Browse Branches

Not provided