SUV Max as Predictor of Outcome in Cervical Cancer

This study has been completed.
Sponsor:
Information provided by:
Rambam Health Care Campus
ClinicalTrials.gov Identifier:
NCT01262144
First received: November 23, 2010
Last updated: December 15, 2010
Last verified: November 2010
  Purpose

Cervical Cancer is staged clinically, not surgically. Patients in whom an extensive disease is identified are not usually eligible for surgery. PET-CT is used to support staging. However, some patients received surgery after staging and subsequently require radio/chemotherapy due to findings on operation.

This study will attempt to find a correlation between SUV-Max on PET-CT and subsequent outcomes i.e. need for adjuvant therapy.


Condition Intervention
Cervical Cancer
Radiation: Radiotherapy

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: A Study to Evaluate the Value of SUV-Max in PET-FDG in Predicting Outcome of Surgery Vis a Vis Need for Radiotherapy

Resource links provided by NLM:


Further study details as provided by Rambam Health Care Campus:

Primary Outcome Measures:
  • Administration of adjuvant therapy [ Time Frame: immediately following surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: surgery - present day ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: August 2010
Groups/Cohorts Assigned Interventions
Case group Radiation: Radiotherapy
Radiotherapy for cervical cancer

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Females age 18-80, diagnosed with cervical cancer

Criteria

Inclusion Criteria:

  • having stating PET-CT stored on site
  • treated with surgery

Exclusion Criteria:

  • not eligible for surgery based on PET-CT, clinical stage
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01262144

Locations
Israel
Rambam Medical Center
City, Haifa, Israel
Sponsors and Collaborators
Rambam Health Care Campus
Investigators
Principal Investigator: Amnon Amit, MD Rambam Health Care Campus
  More Information

No publications provided

Responsible Party: Dr. Amit Amnon, director, gynecologic oncology unit, Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT01262144     History of Changes
Other Study ID Numbers: 421CTIL
Study First Received: November 23, 2010
Last Updated: December 15, 2010
Health Authority: Israel: Ministry of Health

Keywords provided by Rambam Health Care Campus:
Cervical Cancer
PET CT
SUV Max

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on July 23, 2014