Blood Collection From People With Ovarian Cancer

NCT02063464 | Completed

• 2 other identifiers: 14005614-C-0056
• Study Type: observational
• Target: 85
• Locations: 1 country
• Sites: 1

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.

Conditions

Ovarian Cancer; Cancer of the Ovary; Ovarian Neoplasms

Keywords

Monocytes; Interferons Alpha and Gamma; tumoricidal; Natural History

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• \- Children are not eligible.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• Christina M Annunziata, M.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2014
• First Posted: February 14, 2014
• Study Start: March 10, 2014
• Primary Completion: March 14, 2016
• Study Completion: November 16, 2016
• Last Updated: May 24, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Clinical data available during the study and indefinitely.
• Access Criteria: Clinical data will be made available via subscription to BTRIS and with the permission of the study PI.

Locations

US (1)