Measurement of the Folate Receptor in Blood

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Royal Marsden NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT00838747
First received: September 5, 2008
Last updated: May 25, 2016
Last verified: May 2016
  Purpose
The folate receptor (FR) is a cell marker that is over expressed on the cell surface of certain cancers, this occurs most frequently in ovarian cancers. Some normal tissues also express the FR, however in these normal tissues the FR is usually located on the tissue surface that is inaccessible to circulating drugs. As such, drugs which target the FR may potentially be used to achieve anti-tumour efficacy whilst reducing toxicity to normal tissues. Therefore the ability to measure FR levels from different cancer types may help to select patients who are most likely to benefit from treatment with FR targeted therapies. One such drug BGC 945 is currently being tested in preclinical study at The Institute of Cancer Research

Condition
Healthy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Measurement of the Folate Receptor in Blood

Resource links provided by NLM:


Further study details as provided by Royal Marsden NHS Foundation Trust:

Primary Outcome Measures:
  • To measure the levels of folate receptor in blood samples obtained from patients with ovarian cancer and from healthy volunteers [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 7
Study Start Date: September 2008
Study Completion Date: July 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Gynaecological Cancer
Gynaecological Cancer

Detailed Description:
A method has been developed in the laboratory which has been able to measure FR obtained from cancer cells in culture that has been added into blood. We would like to study if this method can measure FR in plasma and serum obtained from patients with ovarian cancer. We would also like to analyse plasma and serum samples obtained from healthy volunteers to determine if they have any appreciable levels of FR, which can then be compared to the measurements obtained from cancer patients.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients with ovarian cancer and healthy volunteers
Criteria

Inclusion Criteria:

  • Patients with stage III/IV ovarian cancer
  • healthy volunteers who are staff at the ICR and RMH

Exclusion Criteria:

  • patients or healthy volunteers who are unable to give informed consent
  • pregnancy
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00838747

Locations
United Kingdom
Royal Marsden NHS Foundation Trust
London, Sutton, United Kingdom, SM2 5PT
Sponsors and Collaborators
Royal Marsden NHS Foundation Trust
Investigators
Principal Investigator: Stan Kaye, Professor Royal Marsden NHS Foundation Trust
  More Information

Responsible Party: Royal Marsden NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT00838747     History of Changes
Other Study ID Numbers: CCR3028 
Study First Received: September 5, 2008
Last Updated: May 25, 2016
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Royal Marsden NHS Foundation Trust:
folate receptor
blood samples
ovarian cancer
development of measure of folate receptor in blood samples
possible selection of patients for treatment with FR targeted agents

Additional relevant MeSH terms:
Folic Acid
Vitamin B Complex
Hematinics
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 25, 2016