Blood Collection From People With Ovarian Cancer

Sponsor

National Cancer Institute (NCI) (NIH)

Overall Status

Completed

CT.gov ID

NCT02063464

Collaborator

(none)

Enrollment

Location

32.3

Actual Duration (Months)

2.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.
In addition, native host anti-tumor cell mediated immune mechanisms may play a role in clinical outcome of epithelial ovarian cancer; data indicate that the presence of intra-tumoral CD3+ T-cells was shown to prognosticate improved outcome in advanced ovarian cancer. Furthermore, non-cellular components in the blood, such as exosomes, may influence outcome.

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 or Disease	Intervention/Treatment	Phase
Ovarian Cancer Cancer of the Ovary Ovarian Neoplasms

Detailed Description

Background:

Using both in vitro and in vivo assays we have shown that human monocytes primed with Interferons alpha and gamma are tumoricidal 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, Primary Peritoneal, or Fallopian Tube Cancer have tumoricidal properties. In addition, native host anti-tumor cell mediated immune mechanisms may play a role in clinical outcome of epithelial ovarian cancer; data indicate that the presence of intra-tumoral CD3+ T-cells was shown to prognosticate improved outcome in advanced ovarian cancer. Furthermore, noncellular components in the blood, such as exosomes, may influence outcome.

Objectives:

To obtain blood samples from patients with ovarian, primary peritoneal or fallopian tube cancer.

Eligibility:

Females greater than or equal to 18 years of age with a prior diagnosis of ovarian, primary peritoneal or fallopian tube 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, primary peritoneal or fallopian tube cancer who are not currently on therapy and are screening for trials, being seen in consultation, or presenting for enrollment on a clinical trial.

Study Design

Study Type:

Observational

Actual Enrollment :

85 participants

Observational Model:

Cohort

Time Perspective:

Cross-Sectional

Official Title:

Collection of Blood From Patients With Ovarian, Primary Peritoneal or Fallopian Tube Cancer

Actual Study Start Date :

Mar 10, 2014

Actual Primary Completion Date :

Mar 14, 2016

Actual Study Completion Date :

Nov 16, 2016

Arms and Interventions

Arm	Intervention/Treatment
Cohort 1 Subjects w/ovarian, primary peritoneal or fallopian tube ca who are not currently on therapy and are screening for trials, being seen in consultation, or presenting for enrollment on a trial.

Outcome Measures

Primary Outcome Measures

To obtain blood samples from patients with ovarian, primary peritoneal or fallopian tube cancer [Single blood collection upon enrollment]
A collection of blood samples from patients with ovarian, primary peritoneal or fallopian tube cancer

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

INCLUSION CRITERIA
Females greater than or equal to 18 years of age with histologically proven ovarian, primary peritoneal or fallopian tube 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