Ovarian CancerNCT03189108
Collection of Malignant Ascites, Pleural Fluid, and Blood From People With Solid Tumors
An observational study of Ovarian Cancer and Primary Peritoneal Cancer, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Background: Researchers want to study fluids and blood of people with cancer. The fluids are from the abdomen and around the lungs. Studying these might help researchers learn about the biology of cancer. This may lead to better ways to treat cancer. Objectives: To study the biology of cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ovarian Cancer, Primary Peritoneal Cancer, Fallopian Tube Cancer
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 22 May 2017to 18 May 2023
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who are being seen in follow up, consultation, or presenting for enrollment on a clinical trial at the NIH Clinical Center
Who may be able to join
- Participants greater than or equal to 18 years of age with histologically proven malignant solid tumors
- Ability and willingness to provide informed consent to participation.
- Participants with malignant solid tumors with a clinical indication for a thoracentesis or paracentesis.
Who cannot join
- -Children < 18 years of age 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 Malignant Ascites, Pleural Fluid and Blood From Patients With Solid Tumors
Background:
Researchers want to study fluids and blood of people with cancer. The fluids are from the abdomen and around the lungs. Studying these might help researchers learn about the biology of cancer. This may lead to better ways to treat cancer.
Read more
Objectives:
To study the biology of cancer.
Eligibility:
Adults 18 and older with malignant solid tumors.
Design:
Participants will be screened with medical history, blood tests, and confirmation of diagnosis.
Participants will have samples taken at regularly scheduled procedures. Fluids from the abdomen and/or lungs will be taken as part of the procedures. Blood will be taken separately.
Participants may be asked to give more samples at future procedures.
Read the detailed description
Background:
-Malignant ascites or pleural effusions are often seen in patients with solid tumor
malignancies.
-Malignant ascites is proinflammatory with many cytokines present and acts to promote
tumor cell growth.
-The cellular composition of malignant ascites consists of lymphocytes, macrophages and
monocytes.
-Serum monocytes and lymphocytes play a role in the native host anti-tumor immune
mediated mechanisms.
-A paracentesis or thoracentesis is often done for symptomatic relief from the malignant
fluid collection.
Primary Objective:
-To obtain blood samples and ascites and pleural effusion samples from patients with solid
tumor malignancies, with the intent of performing translational studies related to cancer.
Eligibility:
- Patients greater than or equal to 18 years of age.
- Diagnosis of malignant solid tumor.
- Patients must be able and willing to provide informed consent.
Design:
-We will collect approximately 200cc-5L ascites from patients that are undergoing a
therapeutic paracentesis or thoracentesis. No thoracentesis or paracentesis will be
performed solely for research purposes.
-The fluid will be collected during the medical procedure and may be collected at more
than one time point.
-We will also collect 30ml of peripheral blood. This will be from patients who are being
seen in follow up, consultation, or presenting for enrollment on a clinical trial.
- Keywords
- Malignant Effusion Composition, Paracentesis, Thoracentesis, Natural History
- Medical subject headings
- Ovarian Neoplasms, Fallopian Tube Neoplasms, 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 | Patients with a diagnosis of malignant solid tumor |
What is being measured
The primary outcome is the main question the study is designed to answer.
To obtain blood samples, ascites and pleural effusion samples from patients with solid tumor malignancies, with the intent of performing translational studies related to cancer.
Experimental - Translational study outcomes from the collection/analysis of blood samples; and ascites and pleural effusion samples from patients with solid tumor malignancies.
Measured: Ongoing
Secondary outcomes (6)
Develop the malignant fluid as a culture model to replicate intraperitoneal growth of ovarian cancers.
Measured: ongoing
Characterize malignant effusion composition through immunohistochemistry and flow cytometry.
Measured: ongoing
Compare immune cell phenotype in ascites and blood from the patient.
Measured: ongoing
Study in vivo characteristics of matched tumor cells and peripheral blood leukocytes from the same patient in xenograft models
Measured: ongoing
Establish a bank of clinically annotated samples for translational science.
Measured: ongoing
Compare selected matched sets of samples from the same patient to evaluate both for treatment response.
Measured: ongoing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2017
- Study start22 May 2017
- Primary completion18 May 2023
- Study completion18 May 2023
Why it stopped: PI left NIH
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
- Prospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Kevin C Conlon, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03189108
- Sponsor's protocol ID
- 170100
- Other IDs
- 17-C-0100
- Status last verified
- Dec 2025
- First submitted
- 15 Jun 2017
- Last updated
- 2 Jan 2026
- 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 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collection of Malignant Ascites, Pleural Fluid and Blood From Patients With Solid Tumors
- ClinicalTrials.gov ID
- NCT03189108
- Acronym / sponsor ID
- 170100
- Keywords
- Malignant Effusion Composition, Paracentesis, Thoracentesis, Natural History
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: PI left NIH
- Enrolment
- 22 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 22 May 2017 (actual)
- Primary completion
- 18 May 2023 (actual)
- Study completion
- 18 May 2023 (actual)
- First posted
- 16 Jun 2017 (actual)
- 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:
Researchers want to study fluids and blood of people with cancer. The fluids are from the abdomen and around the lungs. Studying these might help researchers learn about the biology of cancer. This may lead to better ways to treat cancer.
Objectives:
To study the biology of cancer.
Eligibility:
Adults 18 and older with malignant solid tumors.
Design:
Participants will be screened with medical history, blood tests, and confirmation of diagnosis.
Participants will have samples taken at regularly scheduled procedures. Fluids from the abdomen and/or lungs will be taken as part of the procedures. Blood will be taken separately.
Participants may be asked to give more samples at future procedures.
Detailed description
Background:
-Malignant ascites or pleural effusions are often seen in patients with solid tumor
malignancies.
-Malignant ascites is proinflammatory with many cytokines present and acts to promote
tumor cell growth.
-The cellular composition of malignant ascites consists of lymphocytes, macrophages and
monocytes.
-Serum monocytes and lymphocytes play a role in the native host anti-tumor immune
mediated mechanisms.
-A paracentesis or thoracentesis is often done for symptomatic relief from the malignant
fluid collection.
Primary Objective:
-To obtain blood samples and ascites and pleural effusion samples from patients with solid
tumor malignancies, with the intent of performing translational studies related to cancer.
Eligibility:
- Patients greater than or equal to 18 years of age.
- Diagnosis of malignant solid tumor.
- Patients must be able and willing to provide informed consent.
Design:
-We will collect approximately 200cc-5L ascites from patients that are undergoing a
therapeutic paracentesis or thoracentesis. No thoracentesis or paracentesis will be
performed solely for research purposes.
-The fluid will be collected during the medical procedure and may be collected at more
than one time point.
-We will also collect 30ml of peripheral blood. This will be from patients who are being
seen in follow up, consultation, or presenting for enrollment on a clinical trial.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | –Patients with a diagnosis of malignant solid tumor |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are being seen in follow up, consultation, or presenting for enrollment on a clinical trial at the NIH Clinical Center
Key inclusion criteria (3 listed)
- Participants greater than or equal to 18 years of age with histologically proven malignant solid tumors
- Ability and willingness to provide informed consent to participation.
- Participants with malignant solid tumors with a clinical indication for a thoracentesis or paracentesis.
Key exclusion criteria (1 listed)
- -Children < 18 years of age 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, ascites and pleural effusion samples from patients with solid tumor malignancies, with the intent of performing translational studies related to cancer.
Time frame: Ongoing
Experimental - Translational study outcomes from the collection/analysis of blood samples; and ascites and pleural effusion samples from patients with solid tumor malignancies.
6 secondary outcomes
Develop the malignant fluid as a culture model to replicate intraperitoneal growth of ovarian cancers.
Time frame: ongoing
Characterize malignant effusion composition through immunohistochemistry and flow cytometry.
Time frame: ongoing
Compare immune cell phenotype in ascites and blood from the patient.
Time frame: ongoing
Study in vivo characteristics of matched tumor cells and peripheral blood leukocytes from the same patient in xenograft models
Time frame: ongoing
Establish a bank of clinically annotated samples for translational science.
Time frame: ongoing
Compare selected matched sets of samples from the same patient to evaluate both for treatment response.
Time frame: ongoing
Results and safety
The study was stopped early (reason given: PI left NIH). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2026.
- 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.
Kevin C Conlon, 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 Primary Peritoneal Cancer, 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: stopped early, as of the sponsor's last update on 2 Jan 2026. 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 was stopped early (reason given: PI left NIH). Results are not available in the source record.
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, ascites and pleural effusion samples from patients with solid tumor malignancies, with the intent of performing translational studies related to cancer. (time frame: Ongoing). 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 2 Jan 2026.