Fallopian Tube CarcinomaNCT01295489
Biomarkers in Patients With Previously Untreated Invasive Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer
An observational study of Fallopian Tube Carcinoma and Ovarian Carcinoma, run by Gynecologic Oncology Group at 9 sites in United States.
Trial summary
This research trial studies biomarkers in patients with previously untreated invasive ovarian epithelial, fallopian tube, or primary peritoneal cancer. Studying samples of tumor tissue, peritoneal cavity fluid, and blood from patients receiving chemotherapy directly into the abdominal cavity (intraperitoneal) may help… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Fallopian Tube Carcinoma, Ovarian Carcinoma, Primary Peritoneal Carcinoma
- What is being tested?
- Laboratory Biomarker Analysis
- How many people
- 39 participants
- Where
- 9 sitesUnited States
- Study dates
- Mar 2011to Jan 2018
- 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
Who may be able to join
- Patients must be enrolled on GOG-0252
- Patients must have an IP catheter placed prior to initiating platinum and taxane-based chemotherapy on GOG-0252
- Patients must have signed an approved informed consent for specimen collection and participation in this translational research study
Who cannot join
- Patients who are not enrolled on GOG-0252
- Patients who have not had an IP catheter placed prior to initiating platinum and taxane-based IP chemotherapy on GOG-0252
- Patients who did not sign an approved informed consent for specimen collection and participation in this translational research study
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
McFarland Clinic PC-William R Bliss Cancer Center
Ames, Iowa, 50010
Billings Clinic Cancer Center
Billings, Montana, 59101
Roswell Park Cancer Institute
Buffalo, New York, 14263
Riverside Methodist Hospital
Columbus, Ohio, 43214
Sudarshan K Sharma MD Limted-Gynecologic Oncology
Hinsdale, Illinois, 60521
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
Women and Infants Hospital
Providence, Rhode Island, 02905
Memorial Medical Center
Springfield, Illinois, 62781
Oklahoma Cancer Specialists and Research Institute-Tulsa
Tulsa, Oklahoma, 74146
About this study
Official title: A Study of the Local and Systemic Effects of Intraperitoneal Chemotherapy in the Treatment of Previously-Untreated, Invasive Epithelial Ovarian, Fallopian Tube and Primary Peritoneal Carcinoma
This research trial studies biomarkers in patients with previously untreated invasive ovarian epithelial, fallopian tube, or primary peritoneal cancer. Studying samples of tumor tissue, peritoneal cavity fluid, and blood from patients receiving chemotherapy directly into the abdominal cavity (intraperitoneal) may help doctors learn more about the effects of intraperitoneal chemotherapy on cells. It may also help doctors identify and learn more about biomarkers related to cancer.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine the feasibility of obtaining peritoneal fluid, peritoneal washings, and peripheral blood in patients receiving intraperitoneal (IP) chemotherapy for ovarian cancer at multiple institutions.
II. Assess the recovery and viability of peripheral blood mononuclear cells and immune cell subsets in peritoneal fluid and washings.
III. Assess the amount of peritoneal fluid that can be obtained pre-treatment and at specified time points during the course of IP chemotherapy.
IV. Quantify the type and number of cells in peritoneal fluid, peritoneal washings, and blood recovered from women before and during treatment with platinum and taxane based IP chemotherapy.
- Determine the levels of immunomodulatory cytokines in peritoneal fluid, peritoneal washings, and blood recovered from women before and during treatment with platinum and taxane based IP chemotherapy.
VI. Generate exploratory information on the impact of platinum and taxane based IP chemotherapy on immunomodulatory cytokines and tumor-associated alterations in cell phenotypes of peritoneal fluid, peritoneal washings, and blood.
VII. To determine the feasibility of obtaining peritoneal fluid, peritoneal washings, and peripheral blood in patients receiving intravenous (IV) chemotherapy for ovarian cancer at multiple institutions (limited to patients that receive an IP catheter at the time of surgery and the catheter is left in by the investigator, but are subsequently treated with IV chemotherapy).
VIII. Assess the amount of peritoneal fluid that can be obtained pre-treatment and at specified time points during the course of IV chemotherapy.
IX. Assess the recovery and viability of peripheral blood mononuclear cells and immune cell subsets in peritoneal fluid and washings.
- Quantify the type and number of immune cells in peritoneal fluid, peritoneal washings, and blood recovered from women before and during treatment with platinum and taxane based IV chemotherapy.
XI. Determine levels of immunomodulatory cytokines in peritoneal fluid, peritoneal washings, and blood recovered from women before and during treatment with platinum and taxane-based IV chemotherapy.
XII. Generate exploratory information on the impact of platinum and taxane based IV chemotherapy on immunomodulatory cytokines tumor-associated alterations in cell phenotypes of peritoneal fluid, peritoneal washings, and blood.
XIII. Explore whether there is a relationship between immune cell populations measured in peripheral blood, peritoneal fluid, and peritoneal washings AND immune cell subsets measured by immunohistochemistry in archival formalin-fixed, paraffin-embedded tumor tissue.
OUTLINE: Patients are assigned to a group based on which arm of treatment they are randomized to receive on Gynecologic Oncology Group (GOG)-0252.
GROUP A (IP CATHETER REMOVED): Archival formalin-fixed, paraffin-embedded tumor (collected during previous surgery), peritoneal fluid, peritoneal wash, and blood (for cell, plasma, and serum isolation) samples are collected before course one and blood (for cell, plasma, and serum isolations) is collected before courses two and three for translational research.
GROUP B (IP CATHETER IN PLACE): Archival formalin-fixed, paraffin-embedded tumor (collected during previous surgery), peritoneal fluid, peritoneal wash, and blood (for cell, plasma, and serum isolation) samples are collected before course one and peritoneal fluid, peritoneal wash, and blood (for cell, plasma, and serum isolations) before courses two and three for translational research.
- Being tested
- Laboratory Biomarker Analysis
- Medical subject headings
- Fallopian Tube Neoplasms, Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laboratory Biomarker AnalysisOther
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Group A (IP catheter removed) | Archival formalin-fixed, paraffin-embedded tumor (collected during previous surgery), peritoneal fluid, peritoneal wash, and blood (for cell, plasma, and serum isolation) samples are collected before course one and blood (for cell, plasma, and serum isolations) is collected before courses two and three for translational research. Receives: Other: Laboratory Biomarker Analysis | |
| Group B (IP catheter in place) | Archival formalin-fixed, paraffin-embedded tumor (collected during previous surgery), peritoneal fluid, peritoneal wash, and blood (for cell, plasma, and serum isolation) samples are collected before course one and peritoneal fluid, peritoneal wash, and blood (for cell, plasma, and serum isolations) before courses two and three for translational research. Receives: Other: Laboratory Biomarker Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of peritoneal fluid obtained during each attempted extraction of peritoneal fluid or washing
Measured: Up to 1 year
Presence of immune cells measured by immunohistochemistry in archival formalin-fixed, paraffin-embedded tumor tissue
The staining intensities of immune cells detected in immunohistochemically stained paraffin tissue will be described using descriptive statistics such as the median, 1st and 3rd quartiles of staining intensities. Spearman's correlation coefficient will be used to assess associations between these intensities and the cell counts obtained from pre-treatment peripheral blood and peritoneal fluids. Boxplots or scattergrams will be used to display these data.
Measured: Up to 1 year
Quantity of each type of immune cells identified in the peritoneal fluid or washings specimens
A Wilcoxon signed rank test will be used to evaluate the null hypothesis that the expectation of the pretreatment cell counts is equal to the expectation of the post-treatment cell count. Descriptive statistics such as the mean, variance, median, 1st and 3rd quartiles as well as the spearman correlation between pre- and post- treatment cell counts will be reported for each cell type. Boxplots or scattergrams will be used to display the results. The mean, variance and quartiles of the amount of fluid recovered from pre-treatment and post-treatment samples will also be reported.
Measured: Up to 1 year
Quantity of each type of mononuclear cells in peripheral blood
The number and type of mononuclear cells in peripheral blood will be described using descriptive statistics such as the median, 1st and 3rd quartiles. Spearman's correlation coefficient will be used to assess associations between pre- and post- treatment values. Boxplots or scattergrams will be used to display these data. A Wilcoxon signed rank test, that involves the patients' pre- and post- treatment measurements, will be used to evaluate the null hypothesis that these cell counts are unchanged by treatment.
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2011 (estimated)
- Study startMar 2011
- Primary completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fallopian Tube CarcinomaStudies of the same condition, open and under way.
- 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
- Enrolment
- 39 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gynecologic Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Robert Edwards, Principal investigator, NRG Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01295489
- Sponsor's protocol ID
- GOG-0271
- Other IDs
- NCI-2011-02871, CDR0000695260, GOG-0271, GOG-0271, U10CA180868, U10CA027469
- Status last verified
- May 2018
- First submitted
- 11 Feb 2011
- Last updated
- 22 May 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the Local and Systemic Effects of Intraperitoneal Chemotherapy in the Treatment of Previously-Untreated, Invasive Epithelial Ovarian, Fallopian Tube and Primary Peritoneal Carcinoma
- ClinicalTrials.gov ID
- NCT01295489
- Acronym / sponsor ID
- GOG-0271
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- Gynecologic Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Mar 2011
- Primary completion
- Jan 2018 (actual)
- First posted
- 14 Feb 2011 (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.
This research trial studies biomarkers in patients with previously untreated invasive ovarian epithelial, fallopian tube, or primary peritoneal cancer. Studying samples of tumor tissue, peritoneal cavity fluid, and blood from patients receiving chemotherapy directly into the abdominal cavity (intraperitoneal) may help doctors learn more about the effects of intraperitoneal chemotherapy on cells. It may also help doctors identify and learn more about biomarkers related to cancer.
Detailed description
PRIMARY OBJECTIVES:
- To determine the feasibility of obtaining peritoneal fluid, peritoneal washings, and peripheral blood in patients receiving intraperitoneal (IP) chemotherapy for ovarian cancer at multiple institutions.
II. Assess the recovery and viability of peripheral blood mononuclear cells and immune cell subsets in peritoneal fluid and washings.
III. Assess the amount of peritoneal fluid that can be obtained pre-treatment and at specified time points during the course of IP chemotherapy.
IV. Quantify the type and number of cells in peritoneal fluid, peritoneal washings, and blood recovered from women before and during treatment with platinum and taxane based IP chemotherapy.
- Determine the levels of immunomodulatory cytokines in peritoneal fluid, peritoneal washings, and blood recovered from women before and during treatment with platinum and taxane based IP chemotherapy.
VI. Generate exploratory information on the impact of platinum and taxane based IP chemotherapy on immunomodulatory cytokines and tumor-associated alterations in cell phenotypes of peritoneal fluid, peritoneal washings, and blood.
VII. To determine the feasibility of obtaining peritoneal fluid, peritoneal washings, and peripheral blood in patients receiving intravenous (IV) chemotherapy for ovarian cancer at multiple institutions (limited to patients that receive an IP catheter at the time of surgery and the catheter is left in by the investigator, but are subsequently treated with IV chemotherapy).
VIII. Assess the amount of peritoneal fluid that can be obtained pre-treatment and at specified time points during the course of IV chemotherapy.
IX. Assess the recovery and viability of peripheral blood mononuclear cells and immune cell subsets in peritoneal fluid and washings.
- Quantify the type and number of immune cells in peritoneal fluid, peritoneal washings, and blood recovered from women before and during treatment with platinum and taxane based IV chemotherapy.
XI. Determine levels of immunomodulatory cytokines in peritoneal fluid, peritoneal washings, and blood recovered from women before and during treatment with platinum and taxane-based IV chemotherapy.
XII. Generate exploratory information on the impact of platinum and taxane based IV chemotherapy on immunomodulatory cytokines tumor-associated alterations in cell phenotypes of peritoneal fluid, peritoneal washings, and blood.
XIII. Explore whether there is a relationship between immune cell populations measured in peripheral blood, peritoneal fluid, and peritoneal washings AND immune cell subsets measured by immunohistochemistry in archival formalin-fixed, paraffin-embedded tumor tissue.
OUTLINE: Patients are assigned to a group based on which arm of treatment they are randomized to receive on Gynecologic Oncology Group (GOG)-0252.
GROUP A (IP CATHETER REMOVED): Archival formalin-fixed, paraffin-embedded tumor (collected during previous surgery), peritoneal fluid, peritoneal wash, and blood (for cell, plasma, and serum isolation) samples are collected before course one and blood (for cell, plasma, and serum isolations) is collected before courses two and three for translational research.
GROUP B (IP CATHETER IN PLACE): Archival formalin-fixed, paraffin-embedded tumor (collected during previous surgery), peritoneal fluid, peritoneal wash, and blood (for cell, plasma, and serum isolation) samples are collected before course one and peritoneal fluid, peritoneal wash, and blood (for cell, plasma, and serum isolations) before courses two and three for translational research.
Study design
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (IP catheter removed) | – | Other: Laboratory Biomarker AnalysisArchival formalin-fixed, paraffin-embedded tumor (collected during previous surgery), peritoneal fluid, peritoneal wash, and blood (for cell, plasma, and serum isolation) samples are collected before course one and blood (for cell, plasma, and serum isolations) is collected before courses two and three for translational research. |
| Group B (IP catheter in place) | – | Other: Laboratory Biomarker AnalysisArchival formalin-fixed, paraffin-embedded tumor (collected during previous surgery), peritoneal fluid, peritoneal wash, and blood (for cell, plasma, and serum isolation) samples are collected before course one and peritoneal fluid, peritoneal wash, and blood (for cell, plasma, and serum isolations) before courses two and three for translational research. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients must be enrolled on GOG-0252
- Patients must have an IP catheter placed prior to initiating platinum and taxane-based chemotherapy on GOG-0252
- Patients must have signed an approved informed consent for specimen collection and participation in this translational research study
Key exclusion criteria (3 listed)
- Patients who are not enrolled on GOG-0252
- Patients who have not had an IP catheter placed prior to initiating platinum and taxane-based IP chemotherapy on GOG-0252
- Patients who did not sign an approved informed consent for specimen collection and participation in this translational research study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laboratory Biomarker AnalysisCorrelative studies | Other | Group A (IP catheter removed), Group B (IP catheter in place) |
Primary outcome
Amount of peritoneal fluid obtained during each attempted extraction of peritoneal fluid or washing
Time frame: Up to 1 year
Presence of immune cells measured by immunohistochemistry in archival formalin-fixed, paraffin-embedded tumor tissue
Time frame: Up to 1 year
The staining intensities of immune cells detected in immunohistochemically stained paraffin tissue will be described using descriptive statistics such as the median, 1st and 3rd quartiles of staining intensities. Spearman's correlation coefficient will be used to assess associations between these intensities and the cell counts obtained from pre-treatment peripheral blood and peritoneal fluids. Boxplots or scattergrams will be used to display these data.
Quantity of each type of immune cells identified in the peritoneal fluid or washings specimens
Time frame: Up to 1 year
A Wilcoxon signed rank test will be used to evaluate the null hypothesis that the expectation of the pretreatment cell counts is equal to the expectation of the post-treatment cell count. Descriptive statistics such as the mean, variance, median, 1st and 3rd quartiles as well as the spearman correlation between pre- and post- treatment cell counts will be reported for each cell type. Boxplots or scattergrams will be used to display the results. The mean, variance and quartiles of the amount of fluid recovered from pre-treatment and post-treatment samples will also be reported.
Quantity of each type of mononuclear cells in peripheral blood
Time frame: Up to 1 year
The number and type of mononuclear cells in peripheral blood will be described using descriptive statistics such as the median, 1st and 3rd quartiles. Spearman's correlation coefficient will be used to assess associations between pre- and post- treatment values. Boxplots or scattergrams will be used to display these data. A Wilcoxon signed rank test, that involves the patients' pre- and post- treatment measurements, will be used to evaluate the null hypothesis that these cell counts are unchanged by treatment.
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 22 May 2018.
Related trials for Fallopian Tube Carcinoma
RecruitingPhase 2
Investigation of Ubamatamab Combination Therapy in Adult Participants With Platinum-Resistant Ovarian Cancer
Ovarian Cancer, Fallopian Tube Cancer
RecruitingPhase 3
Torvutatug Samrotecan Plus Bevacizumab as First-line Maintenance in Non-Homologous Recombination Deficiency (Non-HRD) Positive Advanced Epithelial Ovarian Cancer
Epithelial Ovarian Cancer
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingObservational study
Clonal Hematopoiesis and Therapy-Emergent Myeloid Neoplasms in Patients With Cancers, CHANCES Study
Recurrent Fallopian Tube Carcinoma, Recurrent Ovarian Carcinoma
RecruitingPhase 3
A Study of Raludotatug Deruxtecan With or Without Bevacizumab as First-Line Maintenance Treatment in Non-HRD-Positive Advanced Ovarian Cancer (MK-5909-006, (ENGOT-ov102/GOG-3141/ REJOICE-Ovarian 04)
Ovarian Cancer, Ovarian Neoplasms
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.
Robert Edwards principal investigator
NRG Oncology
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fallopian Tube Carcinoma and Ovarian Carcinoma, run by Gynecologic Oncology Group at 9 sites 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 3 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 22 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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?
Amount of peritoneal fluid obtained during each attempted extraction of peritoneal fluid or washing (time frame: Up to 1 year). The study lists 4 primary outcomes in all. 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 22 May 2018.