Ovarian CancerNCT02063464
Blood Collection From People With Ovarian Cancer
An observational study of Ovarian Cancer and Cancer of the Ovary, run by National Cancer Institute (NCI) at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer, Cancer of the Ovary, Ovarian Neoplasms
- How many people
- 85 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Mar 2014to 16 Nov 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Children are not eligible.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: Collection of Blood From Patients With Ovarian, Primary Peritoneal or Fallopian Tube Cancer
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.
Read more
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.
Read the 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.
- Conditions
- Ovarian Cancer, Cancer of the Ovary, Ovarian Neoplasms
- Keywords
- Monocytes, Interferons Alpha and Gamma, tumoricidal, Natural History
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Single blood collection upon enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2014 (estimated)
- Study start10 Mar 2014
- Primary completion14 Mar 2016
- Study completion16 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Christina M Annunziata, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02063464
- Sponsor's protocol ID
- 140056
- Other IDs
- 14-C-0056
- Status last verified
- May 2023
- First submitted
- 13 Feb 2014
- Last updated
- 24 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: .All IPD recorded in the medical record will be shared with intramural investigators upon request.
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collection of Blood From Patients With Ovarian, Primary Peritoneal or Fallopian Tube Cancer
- ClinicalTrials.gov ID
- NCT02063464
- Acronym / sponsor ID
- 140056
- Conditions
- Ovarian Cancer, Cancer of the Ovary, Ovarian Neoplasms
- Keywords
- Monocytes, Interferons Alpha and Gamma, tumoricidal, Natural History
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 10 Mar 2014 (actual)
- Primary completion
- 14 Mar 2016 (actual)
- Study completion
- 16 Nov 2016 (actual)
- First posted
- 14 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Children are not eligible.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2023.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. .All IPD recorded in the medical record will be shared with intramural investigators upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christina M Annunziata, M.D. principal investigator
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ovarian Cancer and Cancer of the Ovary, run by National Cancer Institute (NCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To obtain blood samples from patients with ovarian, primary peritoneal or fallopian tube cancer (time frame: Single blood collection upon enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2023.