Trial record 3 of 426 for:    Open Studies | "Ovarian Neoplasms"

Blood Collection From People With Ovarian Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )
ClinicalTrials.gov Identifier:
NCT02063464
First received: February 13, 2014
Last updated: March 14, 2014
Last verified: January 2014
  Purpose

Background:

- Monocytes are a type of white blood cell found in human blood. They help the immune system. Researchers have found that monocytes taken from the blood of healthy people can kill tumor cells. Now they want to know if monocytes taken from the blood of people with ovarian cancer can kill tumor cells.

Objective:

- To see if monocytes taken from the blood of people with ovarian cancer can kill tumor cells.

Eligibility:

- Women 18 years and older with ovarian cancer.

Design:

  • Participants will be screened with:
  • Medical history and physical exam.
  • Blood tests.
  • CT scan of the chest, abdomen, and pelvis and/or an MRI. For these scans, they will lie in a machine that takes pictures of their body.
  • A small amount of blood (two tubes) will be collected by needle during one visit.

Condition
Ovarian Cancer
Cancer of the Ovary
Ovarian Neoplasms

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Collection of Blood From Patients With Ovarian Cancer

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • The primary outcome will be the collection of macrophages from the blood samples, and the functional testing of these cells. [ Time Frame: 4 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: January 2014
Estimated Study Completion Date: November 2017
Estimated Primary Completion Date: November 2017 (Final data collection date for primary outcome measure)
Detailed Description:

Background:

Using both in vitro and in vivo assays we have shown that human monocytes primed with Interferons alpha and gamma are tumorcidal and are capable of killing a number of tumor cell lines and human tumors implanted into immunocompromised mice. We have shown that monocytes isolated through elutriation at the NIH blood bank and monocytes isolated from anticoagulated peripheral blood from healthy women from the NIH blood bank are equally capable of killing tumor cells. No data have been collected as to whether monocytes from patients with Ovarian Cancer have tumorcidal properties. The goal of this protocol is to measure the tumorcidal properties of monocytes from patients with Ovarian Cancer.

Objectives:

To obtain blood samples from patients with ovarian cancer.

Eligibility:

Females greater than or equal to 18 years of age with a prior diagnosis of ovarian cancer seen in the Women s Cancer Clinic of the NCI. Patients must be able and willing to provide informed consent.

Design:

We will collect approximately 20 ml of peripheral blood at a single time point from patients with ovarian cancer who are not currently on therapy and are screening for trials, being seen in consultation, or presenting for enrollment on a clinical trial.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA
  • Females greater than or equal to 18 years of age with histologically proven ovarian cancer.
  • Currently not on therapy. Must be at least 2 weeks from prior therapy.
  • Ability and willingness to provide informed consent to participation.

EXCLUSION CRITERIA

- Children are not eligible.

  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: NCT02063464

Contacts
Contact: Irene Ekwede (301) 402-6225 irene.ekwede@nih.gov
Contact: Christina M Annunziata, M.D. (301) 402-7189 ca180n@nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office    888-624-1937      
Sponsors and Collaborators
Investigators
Principal Investigator: Christina M Annunziata, M.D. National Cancer Institute (NCI)
  More Information

Additional Information:
Publications:
Responsible Party: National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )
ClinicalTrials.gov Identifier: NCT02063464     History of Changes
Other Study ID Numbers: 140056, 14-C-0056
Study First Received: February 13, 2014
Last Updated: March 14, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Tumorcidal
Monocytes
Interferons Alpha and Gamma

Additional relevant MeSH terms:
Ovarian Neoplasms
Adnexal Diseases
Endocrine Gland Neoplasms
Endocrine System Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Gonadal Disorders
Neoplasms
Neoplasms by Site
Ovarian Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on October 22, 2014