Clinical trial NCT02063464: Blood Collection From People With Ovarian Cancer
Official title: Collection of Blood From Patients With Ovarian, Primary Peritoneal or Fallopian Tube Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ovarian Cancer
Cancer of the Ovary
Ovarian Neoplasms
Keywords: Monocytes
Interferons Alpha and Gamma
tumoricidal
Natural History
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2014-02-14
Enrollment: 85
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants w/ovarian, primary peritoneal or fallopian tube cancer who are screening for trials, being seen in consultation, or presenting for enrollment on a clinical trial at the NIH Clinical Center.

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.

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.

Eligibility criteria: * 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

- Children are not eligible.

Primary outcomes:
measure: To obtain blood samples from patients with ovarian, primary peritoneal or fallopian tube cancer
timeFrame: Single blood collection upon enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Institutes of Health Clinical Center
state: Maryland
Study officials:
affiliation: National Cancer Institute (NCI)
name: Christina M Annunziata, M.D.
role: PRINCIPAL_INVESTIGATOR
References: