Blood Collection From People With Ovarian Cancer

Ovarian Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02063464
• Other study ID #: 140056
• Secondary ID: 14-C-0056
• Status: Completed
• Start date: March 10, 2014
• Est. completion date: November 16, 2016

Study information

• Verified date: May 2023
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: November 16, 2016
• Est. primary completion date: March 14, 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

• 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.

Related Conditions & MeSH terms

• Cancer of the Ovary
• Carcinoma, Ovarian Epithelial
• Ovarian Cancer
• Ovarian Neoplasms

Locations

Country	Name	City	State
United States	National Institutes of Health Clinical Center	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To obtain blood samples from patients with ovarian, primary peritoneal or fallopian tube cancer	A collection of blood samples from patients with ovarian, primary peritoneal or fallopian tube cancer	Single blood collection upon enrollment

External Links

•   NIH Clinical Center Detailed Web Page