Blood Collection From People With Ovarian Cancer
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| ClinicalTrials.gov Identifier: NCT02063464 |
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Recruitment Status :
Completed
First Posted : February 14, 2014
Last Update Posted : September 12, 2019
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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 |
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| Ovarian Cancer Cancer of the Ovary Ovarian Neoplasms |
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 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 |
| Study Start Date : | February 13, 2014 |
| Actual Primary Completion Date : | November 16, 2016 |
| Actual Study Completion Date : | November 16, 2016 |
| Group/Cohort |
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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.
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- To obtain blood samples from patients with ovarian, primary peritoneal or fallopian tube cancer [ Time Frame: Single blood collection upon enrollment ]A collection of blood samples from patients with ovarian, primary peritoneal or fallopian tube cancer
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, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 100 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02063464
| United States, Maryland | |
| National Institutes of Health Clinical Center, 9000 Rockville Pike | |
| Bethesda, Maryland, United States, 20892 | |
| Principal Investigator: | Christina M Annunziata, M.D. | National Cancer Institute (NCI) |
Additional Information:
| Responsible Party: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT02063464 History of Changes |
| Other Study ID Numbers: |
140056 14-C-0056 |
| First Posted: | February 14, 2014 Key Record Dates |
| Last Update Posted: | September 12, 2019 |
| Last Verified: | September 10, 2019 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Tumorcidal Monocytes Interferons Alpha and Gamma |
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Ovarian Neoplasms Carcinoma, Ovarian Epithelial Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female |
Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |