- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06240598
A Study of Second Look Laparoscopy (SLL) in People With Ovarian Cancer Who Have Completed Their First Course of Chemotherapy
February 26, 2026 updated by: Memorial Sloan Kettering Cancer Center
Identification of Markers of Resistance During Frontline Therapy and Maintenance
The researchers are doing this study to look at the health outcomes of people with advanced ovarian cancer who have a second look laparoscopy (SLL) after they complete their first course of chemotherapy.
The researchers will compare the health outcomes of people who have minimal residual disease (MRD-small amounts of cancer cells in the body after a person receives treatment) at the time of SLL with the health outcomes of people who do not have MRD at the time of SLL.
The researchers are also doing this study to determine if SLL is safe and practical (feasible) in people with advanced ovarian cancer who have completed the first course of therapy for their disease.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
10
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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New Jersey
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Basking Ridge, New Jersey, United States, 07920
- Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
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Middletown, New Jersey, United States, 07748
- Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
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Montvale, New Jersey, United States, 07645
- Memorial Sloan Kettering Bergen (Limited Protocol Activities)
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New York
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Commack, New York, United States, 11725
- Memorial Sloan Kettering Suffolk -Commack (Limited Protocol Activities)
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Harrison, New York, United States, 10604
- Memorial Sloan Kettering Westchester (Limited Protocol Activities)
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New York, New York, United States, 10065
- Memorial Sloan Kettering Cancer Center
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Uniondale, New York, United States, 11553
- Memorial Sloan Kettering Nassau (Limited Protocol Activities)
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Patients assigned female at birth≥ 18 years of age
- Suspected or known stage III-IV epithelial ovarian cancer for which the patient has undergone, or is planned to undergo, attempted primary or interval debulking surgery
Homologous Recombination Deficiency testing should be planned to be completed prior to completion of initial platinum/taxane chemotherapy. HRD testing can be determined using :
- Confirmation of deleterious Somatic or Germline BRCA mutation
- CLIA certified test for HRD
- Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
Exclusion Criteria:
- Patients with the inability to swallow oral medications or impaired gastrointestinal absorption due to gastrectomy or drainage gastrostomy tube
- Patients receiving standard of care or investigational protocol directed treatment are eligible for this study, with the exception of protocol directed treatment which would prohibit the SLL surgery from being performed
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Second Look Laparoscopy (SLL)
Patients will be treated with standard of care observation or maintenance therapy as per investigator decision.The only investigational intervention performed through this study is the SLL.
|
Second Look Laparoscopy (SLL)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
minimal residual disease (MRD) status
Time Frame: up to 12 weeks
|
will be based on surgicopathological findings from multiple biopsies and peritoneal cytology obtained during the SLL procedure
|
up to 12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Rachel Grisham, MD, Memorial Sloan Kettering Cancer Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 26, 2024
Primary Completion (Estimated)
January 1, 2027
Study Completion (Estimated)
January 1, 2027
Study Registration Dates
First Submitted
January 26, 2024
First Submitted That Met QC Criteria
January 26, 2024
First Posted (Actual)
February 5, 2024
Study Record Updates
Last Update Posted (Actual)
February 27, 2026
Last Update Submitted That Met QC Criteria
February 26, 2026
Last Verified
February 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Genital Diseases
- Endocrine System Diseases
- Urogenital Neoplasms
- Neoplasms by Site
- Neoplasms
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Neoplasms by Histologic Type
- Genital Diseases, Female
- Endocrine Gland Neoplasms
- Neoplasms, Glandular and Epithelial
- Ovarian Diseases
- Adnexal Diseases
- Genital Neoplasms, Female
- Gonadal Disorders
- Carcinoma
- Carcinoma, Ovarian Epithelial
- Ovarian Neoplasms
Other Study ID Numbers
- 23-249
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials.
The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov
when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required.
Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication.
Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals.
Requests may be made to: crdatashare@mskcc.org.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Ovarian Cancer
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Roswell Park Cancer InstituteCompletedFallopian Tube Carcinoma | Primary Peritoneal Carcinoma | Stage IIA Ovarian Cancer | Stage IIB Ovarian Cancer | Stage IIC Ovarian Cancer | Stage IIIA Ovarian Cancer | Stage IIIB Ovarian Cancer | Stage IIIC Ovarian Cancer | Stage IV Ovarian Cancer | Stage IA Ovarian Cancer | Stage IB Ovarian Cancer | Stage IC... and other conditionsUnited States
-
Jiangsu Cancer Institute & HospitalRecruitingOvarian Cancer Metastatic | Ovarian Cancer Metastatic RecurrentChina
-
Asan Medical CenterKorean Gynecologic Oncology GroupNot yet recruitingOvarian Cancer Recurrent | Platinum Sensitive Ovarian Cancer
-
City of Hope Medical CenterNational Cancer Institute (NCI)CompletedCancer Survivor | Stage IIIA Ovarian Epithelial Cancer | Stage IIIB Ovarian Epithelial Cancer | Stage IIIC Ovarian Epithelial Cancer | Stage IIA Ovarian Epithelial Cancer | Stage IIB Ovarian Epithelial Cancer | Stage IIC Ovarian Epithelial Cancer | Stage IA Ovarian Epithelial Cancer | Stage IB Ovarian... and other conditionsUnited States
-
Massachusetts General HospitalJohns Hopkins University; M.D. Anderson Cancer Center; National Cancer Institute... and other collaboratorsRecruitingOvarian Neoplasms | Fallopian Tube Neoplasms | Stage III Ovarian Cancer AJCC v8 | Stage IIIA Ovarian Cancer AJCC v8 | Stage IIIA1 Ovarian Cancer AJCC v8 | Stage IIIA2 Ovarian Cancer AJCC v8 | Stage IIIB Ovarian Cancer AJCC v8 | Stage IIIC Ovarian Cancer AJCC v8 | Stage IV Ovarian Cancer AJCC v8 | Stage... and other conditionsUnited States
-
Gynecologic Oncology GroupNational Cancer Institute (NCI)CompletedOvarian Clear Cell Cystadenocarcinoma | Ovarian Endometrioid Adenocarcinoma | Ovarian Seromucinous Carcinoma | Ovarian Serous Cystadenocarcinoma | Stage IV Ovarian Germ Cell Tumor | Ovarian Sarcoma | Malignant Ovarian Epithelial Tumor | Ovarian Carcinosarcoma | Ovarian Brenner Tumor | Ovarian Mucinous... and other conditionsUnited States
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University of California, DavisRecruitingBreast Cancer | Ovarian Cancer | Breast Neoplasm | Breast Carcinoma | Breast Cancer Stage IV | Breast Cancer Stage I | Breast Cancer Stage II | Invasive Breast Cancer | Cancer, Breast | Breast Cancer Stage III | Ovary Cancer | Malignant Tumor of Breast | Ovarian Cancer Stage IIIC | Ovarian Cancer Stage IV | Ovarian Cancer... and other conditionsUnited States
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Centre Leon BerardCancer Côte d'or registry; Cancer Calvados registryUnknownOvarian Epithelial CancerFrance
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Gynecologic Oncology GroupNational Cancer Institute (NCI)TerminatedOvarian Clear Cell Cystadenocarcinoma | Ovarian Endometrioid Adenocarcinoma | Ovarian Seromucinous Carcinoma | Ovarian Serous Cystadenocarcinoma | Nausea and Vomiting | Ovarian Brenner Tumor | Ovarian Mucinous Cystadenocarcinoma | Undifferentiated Ovarian Carcinoma | Stage IIA Fallopian Tube Cancer | Stage... and other conditionsUnited States
-
Gynecologic Oncology GroupNational Cancer Institute (NCI)RecruitingStage IIIA Ovarian Cancer | Stage IIIB Ovarian Cancer | Stage IIIC Ovarian Cancer | Stage IV Ovarian CancerUnited States
Clinical Trials on Second Look Laparoscopy
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Kosin University Gospel HospitalInje UniversityUnknownGastric NeoplasmsKorea, Republic of
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Mansoura UniversityUnknown
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Institut de Cancérologie de LorraineCompleted
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Academisch Medisch Centrum - Universiteit van Amsterdam...Active, not recruitingColorectal Cancer | Peritoneal MetastasesNetherlands
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Charles University, Czech RepublicRecruitingCSF Pressure Increased | CSF Leak | Puncture | CSF Circulation DisorderCzechia
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Insel Gruppe AG, University Hospital BernRecruitingInfection as Complication of Medical Care | Joint (Knee or Hip Replacement)Switzerland
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Zimmer BiometWithdrawn
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Campus Bio-Medico UniversityCompletedBenign Gynecological Pathology
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Wake Forest University Health SciencesNational Cancer Institute (NCI)CompletedPeritoneal Carcinoma | Stage III Fallopian Tube Cancer | Stage II Fallopian Tube Cancer | Ovarian Epithelial Cancer Stage I | Ovarian Epithelial Cancer Stage II | Ovarian Epithelial Cancer Stage III | Stage I Fallopian Tube CancerUnited States
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University of TorontoUnknown