A Pilot Test for Newly Developed Synoptic Operative Templ... | NCT01823731

Studies
A Pilot Test for Newly Developed Synoptic Operative Template for Ovarian Cancer (SOTOC): National Cancer Center - Peritoneal Carcinomatosis Index

NCT01823731

Sponsor

National Cancer Center, Korea

Status

Unknown status

Last Update Posted

Jun 5, 2013Estimated

Enrollment

50Actual

Phase

Not provided

Conditions

Ovarian Cancer

Interventions

Not provided

Countries

Not provided

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

Jun 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2013

Primary Completion Date

Dec 2013Estimated

Completion Date

Dec 2013Estimated

First Submitted Date

Mar 29, 2013

First Submission Date that Met QC Criteria

Mar 29, 2013

First Posted Date

Apr 4, 2013Estimated

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

Jun 4, 2013

Last Update Posted Date

Jun 5, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sang-Yoon Park, Chief, Center for Uterine Cancer, National Cancer Center, KoreaPrincipal Investigator

Lead Sponsor

National Cancer Center, KoreaOTHER_GOV

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

objectives: To development of NCC-PCI-Operative Template (NPOT) for the objective description of perioperative tumor burden and surgical approaches in the management of ovarian cancer, tubal cancer, and primary peritoneal cancer

Detailed Description

Informed consent
Digital photography & Checking PCI (tumor size& location )
Postoperative surveillance(tumor marker, image and physical examination)
Developing the best fitting NCC-PCI template to reflect recurrence and survival pattern

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
evaluation of Clinical Applicability about Synoptic Operative Template for Ovarian Cancer (SOTOC)		one year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Preoperative clinical diagnosis of ovarian cancer, tubal cancer, and primary peritoneal carcinoma
Available preoperative image study (CT and/or MRI and/or PET)
Patients who gave a written informed consent
Patients must be surgical candidate considering medical and psychological condition

Exclusion Criteria:

Patients who refuse to participate or want to withdraw at anytime.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

ovarian cancer, tubal cancer, primary peritoneal cancer, mesothelioma, pseudomyxoma peritonei
Debulking operation

Sampling Method

Non-Probability Sample

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