NCT01823731

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2013

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 29, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 4, 2013

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

June 5, 2013

Status Verified

June 1, 2013

Enrollment Period

11 months

First QC Date

March 29, 2013

Last Update Submit

June 4, 2013

Conditions

Ovarian Cancer

Keywords

PCI,SOTOC, Ovarian cancer

Outcome Measures

Primary Outcomes (1)

  • evaluation of Clinical Applicability about Synoptic Operative Template for Ovarian Cancer (SOTOC)

    one year

Eligibility Criteria

Age20 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief, Center for Uterine Cancer

Study Record Dates

First Submitted

March 29, 2013

First Posted

April 4, 2013

Study Start

January 1, 2013

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

June 5, 2013

Record last verified: 2013-06