- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05646316
Impact of Sentinel Lymph Node Mapping on Patient Reported Lower Extremity Limb Dysfunction in Stage I Endometrial Cancer
A Phase III Trial Of The Impact Of Sentinel Lymph Node Mapping On Patient Reported Lower Extremity Limb Dysfunction In Endometrial Cancer
Study Overview
Status
Intervention / Treatment
Detailed Description
PRIMARY OBJECTIVES:
I. To compare the rates of lower extremity limb dysfunction (defined as a >= 4-point increase in Gynecologic Cancer Lymphedema Questionnaire [GCLQ] symptom score from baseline) in patients with apparent uterine confined endometrial cancer randomized to one of two lymphatic assessment strategies at time of hysterectomy:
Ia. Sentinel lymph node mapping and excision followed by side-specific lymphadenectomy on sides without a sentinel lymph node (SLN) identified according to a National Comprehensive Cancer Network (NCCN) guidelines approved algorithm (Arm 1); Ib. Sentinel lymph node mapping and excision according to an NCCN Guidelines approved algorithm followed by bilateral pelvic +/- para-aortic lymphadenectomy (Arm 2).
SECONDARY OBJECTIVE:
I. To compare changes in lower extremity limb circumference in patients with apparent uterine confined endometrial cancer randomized to one of two lymphatic assessment strategies at time of hysterectomy.
II. To validate the test characteristics of a SLN mapping algorithm including SLN detection rates, rate of perioperative complications, rate of identifying lymphatic metastases, and detection of micrometastases using pathologic ultra-staging.
EXPLORATORY OBJECTIVES:
I. To compare adjuvant therapy decisions in patients with apparent uterine confined endometrial cancer randomized to one of two lymphatic assessment strategies at time of hysterectomy.
II. To explore the impact of patient characteristics (age, body mass index [BMI], race), extent of lymph node dissection, and adjuvant therapy decisions (radiation, chemotherapy) on the development of lower extremity limb dysfunction - as well as their interaction with lymph node assessment strategies.
III. To evaluate the cost-effectiveness of SLN mapping with or without completion of lymphadenectomy for endometrial cancer.
SAFETY OBJECTIVE:
I. To compare progression free and overall survival in patients with apparent uterine confined endometrial cancer randomized to one of two lymphatic assessment strategies at time of hysterectomy.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM 1: Patients receive ICG dye via injection and undergo sentinel lymph node mapping and excision during standard minimally invasive hysterectomy. Lymph nodes around the uterus may be removed if the mapping and excision cannot be completed. Successful mapping requires no additional removal of lymph nodes.
ARM 2: Patients receive ICG dye via injection and undergo sentinel lymph node mapping and excision during standard minimally invasive hysterectomy. Additional lymph nodes around the uterus are removed per standard of care.
Patients in both arms also undergo imaging as clinically indicated and optional blood sample collection throughout the study.
After completion of study intervention, patients are followed every 3 months for one year and at 18 and 24 months.
Study Type
Enrollment (Estimated)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
District of Columbia
-
Washington D.C., District of Columbia, United States, 20037
- Suspended
- George Washington University Medical Center
-
-
Florida
-
Coral Gables, Florida, United States, 33146
- Recruiting
- UM Sylvester Comprehensive Cancer Center at Coral Gables
-
Contact:
- Site Public Contact
- Phone Number: 305-243-2647
-
Principal Investigator:
- Abdulrahman Sinno
-
Deerfield Beach, Florida, United States, 33442
- Recruiting
- UM Sylvester Comprehensive Cancer Center at Deerfield Beach
-
Contact:
- Site Public Contact
- Phone Number: 305-243-2647
-
Principal Investigator:
- Abdulrahman Sinno
-
Doral, Florida, United States, 33166
- Recruiting
- UM Sylvester Comprehensive Cancer Center at Doral
-
Principal Investigator:
- Abdulrahman Sinno
-
Contact:
- Site Public Contact
- Email: kginnity@med.miami.edu
-
Miami, Florida, United States, 33136
- Recruiting
- University of Miami Miller School of Medicine-Sylvester Cancer Center
-
Contact:
- Site Public Contact
- Phone Number: 305-243-2647
-
Principal Investigator:
- Abdulrahman Sinno
-
Miami, Florida, United States, 33176
- Recruiting
- UM Sylvester Comprehensive Cancer Center at Kendall
-
Contact:
- Site Public Contact
- Phone Number: 305-243-2647
-
Principal Investigator:
- Abdulrahman Sinno
-
North Miami, Florida, United States, 33181
- Recruiting
- University of Miami Sylvester Comprehensive Cancer Center at Sole Mia
-
Principal Investigator:
- Abdulrahman Sinno
-
Contact:
- Site Public Contact
- Email: kginnity@med.miami.edu
-
Plantation, Florida, United States, 33324
- Recruiting
- UM Sylvester Comprehensive Cancer Center at Plantation
-
Contact:
- Site Public Contact
- Phone Number: 305-243-2647
-
Principal Investigator:
- Abdulrahman Sinno
-
-
Georgia
-
Augusta, Georgia, United States, 30912
- Recruiting
- Augusta University Medical Center
-
Principal Investigator:
- Sharad A. Ghamande
-
Contact:
- Site Public Contact
- Phone Number: 706-721-2388
- Email: ga_cares@augusta.edu
-
-
Illinois
-
Chicago, Illinois, United States, 60611
- Recruiting
- Northwestern University
-
Contact:
- Site Public Contact
- Phone Number: 312-695-1301
- Email: cancer@northwestern.edu
-
Principal Investigator:
- Emily Hinchcliff
-
Warrenville, Illinois, United States, 60555
- Recruiting
- Northwestern Medicine Cancer Center Warrenville
-
Contact:
- Site Public Contact
- Phone Number: 630-352-5360
- Email: Donald.Smith3@nm.org
-
Principal Investigator:
- Emily Hinchcliff
-
-
Indiana
-
Carmel, Indiana, United States, 46032
- Recruiting
- IU Health North Hospital
-
Contact:
- Site Public Contact
- Phone Number: 317-278-5632
- Email: iutrials@iu.edu
-
Principal Investigator:
- Lisa M. Landrum
-
Indianapolis, Indiana, United States, 46202
- Recruiting
- Indiana University/Melvin and Bren Simon Cancer Center
-
Contact:
- Site Public Contact
- Phone Number: 317-278-5632
- Email: iutrials@iu.edu
-
Principal Investigator:
- Lisa M. Landrum
-
-
Louisiana
-
Marrero, Louisiana, United States, 70072
- Recruiting
- West Jefferson Medical Center
-
Contact:
- Site Public Contact
- Phone Number: 504-210-3539
- Email: emede1@lsuhsc.edu
-
Principal Investigator:
- Tara Castellano
-
Metairie, Louisiana, United States, 70006
- Recruiting
- East Jefferson General Hospital
-
Contact:
- Site Public Contact
- Phone Number: 504-210-3539
- Email: emede1@lsuhsc.edu
-
Principal Investigator:
- Tara Castellano
-
Metairie, Louisiana, United States, 70006
- Recruiting
- LSU Healthcare Network / Metairie Multi-Specialty Clinic
-
Contact:
- Site Public Contact
- Phone Number: 504-210-3539
- Email: emede1@lsuhsc.edu
-
Principal Investigator:
- Tara Castellano
-
New Orleans, Louisiana, United States, 70112
- Recruiting
- University Medical Center New Orleans
-
Contact:
- Site Public Contact
- Phone Number: 504-210-3539
- Email: emede1@lsuhsc.edu
-
Principal Investigator:
- Tara Castellano
-
New Orleans, Louisiana, United States, 70112
- Recruiting
- Louisiana State University Health Science Center
-
Contact:
- Site Public Contact
- Phone Number: 504-210-3539
- Email: emede1@lsuhsc.edu
-
Principal Investigator:
- Tara Castellano
-
-
Maryland
-
Baltimore, Maryland, United States, 21201
- Recruiting
- University of Maryland/Greenebaum Cancer Center
-
Contact:
- Site Public Contact
- Phone Number: 800-888-8823
-
Principal Investigator:
- Gautam G. Rao
-
Bel Air, Maryland, United States, 21014
- Recruiting
- UM Upper Chesapeake Medical Center
-
Contact:
- Site Public Contact
- Phone Number: 443-643-3010
-
Principal Investigator:
- Gautam G. Rao
-
-
Michigan
-
Detroit, Michigan, United States, 48201
- Recruiting
- Wayne State University/Karmanos Cancer Institute
-
Principal Investigator:
- Robert T. Morris
-
Contact:
- Site Public Contact
- Phone Number: 313-576-9790
- Email: ctoadmin@karmanos.org
-
Farmington Hills, Michigan, United States, 48334
- Recruiting
- Weisberg Cancer Treatment Center
-
Principal Investigator:
- Robert T. Morris
-
Contact:
- Site Public Contact
- Phone Number: 313-576-9790
- Email: ctoadmin@karmanos.org
-
Flint, Michigan, United States, 48532
- Recruiting
- McLaren Cancer Institute-Flint
-
Principal Investigator:
- Robert T. Morris
-
Contact:
- Site Public Contact
- Phone Number: 313-576-9790
- Email: ctoadmin@karmanos.org
-
-
Minnesota
-
Edina, Minnesota, United States, 55435
- Recruiting
- Fairview Southdale Hospital
-
Contact:
- Site Public Contact
- Phone Number: 952-993-1517
- Email: mmcorc@healthpartners.com
-
Principal Investigator:
- Britt K. Erickson
-
Maple Grove, Minnesota, United States, 55369
- Recruiting
- Fairview Clinics and Surgery Center Maple Grove
-
Contact:
- Site Public Contact
- Phone Number: 952-993-1517
- Email: mmcorc@healthpartners.com
-
Principal Investigator:
- Britt K. Erickson
-
Maplewood, Minnesota, United States, 55109
- Recruiting
- Saint John's Hospital - Healtheast
-
Contact:
- Site Public Contact
- Phone Number: 952-993-1517
- Email: mmcorc@healthpartners.com
-
Principal Investigator:
- Britt K. Erickson
-
Princeton, Minnesota, United States, 55371
- Recruiting
- Fairview Northland Medical Center
-
Contact:
- Site Public Contact
- Phone Number: 952-993-1517
- Email: mmcorc@healthpartners.com
-
Principal Investigator:
- Britt K. Erickson
-
Saint Paul, Minnesota, United States, 55101
- Recruiting
- Regions Hospital
-
Contact:
- Site Public Contact
- Phone Number: 952-993-1517
- Email: mmcorc@healthpartners.com
-
Principal Investigator:
- Britt K. Erickson
-
Wyoming, Minnesota, United States, 55092
- Recruiting
- Fairview Lakes Medical Center
-
Contact:
- Site Public Contact
- Phone Number: 952-993-1517
- Email: mmcorc@healthpartners.com
-
Principal Investigator:
- Britt K. Erickson
-
-
Missouri
-
Springfield, Missouri, United States, 65804
- Recruiting
- Mercy Hospital Springfield
-
Principal Investigator:
- Jay W. Carlson
-
Contact:
- Site Public Contact
- Phone Number: 417-269-4520
-
-
Montana
-
Billings, Montana, United States, 59101
- Active, not recruiting
- Saint Vincent Healthcare
-
Billings, Montana, United States, 59102
- Active, not recruiting
- Saint Vincent Frontier Cancer Center
-
Billings, Montana, United States, 59106
- Active, not recruiting
- Intermountain Health West End Clinic
-
Butte, Montana, United States, 59701
- Active, not recruiting
- Saint James Community Hospital and Cancer Treatment Center
-
-
Nebraska
-
Kearney, Nebraska, United States, 68845
- Recruiting
- Fred and Pamela Buffett Cancer Center - Kearney
-
Contact:
- Site Public Contact
- Phone Number: 402-559-6941
- Email: unmcrsa@unmc.edu
-
Principal Investigator:
- Kerry J. Rodabaugh
-
Omaha, Nebraska, United States, 68198
- Recruiting
- University of Nebraska Medical Center
-
Contact:
- Site Public Contact
- Phone Number: 402-559-6941
- Email: unmcrsa@unmc.edu
-
Principal Investigator:
- Kerry J. Rodabaugh
-
Omaha, Nebraska, United States, 68118
- Recruiting
- Nebraska Medicine-Village Pointe
-
Contact:
- Site Public Contact
- Phone Number: 402-559-5600
-
Principal Investigator:
- Kerry J. Rodabaugh
-
Omaha, Nebraska, United States, 68124
- Active, not recruiting
- Alegent Health Bergan Mercy Medical Center
-
-
Nevada
-
Las Vegas, Nevada, United States, 89106
- Recruiting
- Women's Cancer Center of Nevada
-
Principal Investigator:
- Nicola M. Spirtos
-
Contact:
- Site Public Contact
- Phone Number: 702-851-4672
-
-
Oklahoma
-
Oklahoma City, Oklahoma, United States, 73104
- Recruiting
- University of Oklahoma Health Sciences Center
-
Contact:
- Site Public Contact
- Phone Number: 405-271-8777
- Email: ou-clinical-trials@ouhsc.edu
-
Principal Investigator:
- Christina Washington
-
-
Pennsylvania
-
Bryn Mawr, Pennsylvania, United States, 19010
- Suspended
- Bryn Mawr Hospital
-
Paoli, Pennsylvania, United States, 19301
- Suspended
- Paoli Memorial Hospital
-
Wynnewood, Pennsylvania, United States, 19096
- Suspended
- Lankenau Medical Center
-
-
Rhode Island
-
Providence, Rhode Island, United States, 02905
- Recruiting
- Women and Infants Hospital
-
Principal Investigator:
- Matthew T. Oliver
-
Contact:
- Site Public Contact
- Phone Number: 401-274-1122
-
-
Texas
-
Dallas, Texas, United States, 75390
- Recruiting
- UT Southwestern/Simmons Cancer Center-Dallas
-
Principal Investigator:
- Jayanthi S. Lea
-
Contact:
- Site Public Contact
- Phone Number: 214-648-7097
- Email: canceranswerline@UTSouthwestern.edu
-
Dallas, Texas, United States, 75235
- Recruiting
- Parkland Memorial Hospital
-
Principal Investigator:
- Jayanthi S. Lea
-
Contact:
- Site Public Contact
- Phone Number: 214-590-5582
- Email: canceranswerline@UTSouthwestern.edu
-
Fort Worth, Texas, United States, 76104
- Recruiting
- UT Southwestern/Simmons Cancer Center-Fort Worth
-
Principal Investigator:
- Jayanthi S. Lea
-
Contact:
- Site Public Contact
- Phone Number: 214-648-7097
- Email: canceranswerline@UTSouthwestern.edu
-
Houston, Texas, United States, 77030
- Recruiting
- Memorial Hermann Texas Medical Center
-
Contact:
- Site Public Contact
- Phone Number: 713-792-3245
-
Principal Investigator:
- Joseph A. Lucci
-
Houston, Texas, United States, 77030
- Active, not recruiting
- Houston Methodist Hospital
-
Houston, Texas, United States, 77070
- Active, not recruiting
- Methodist Willowbrook Hospital
-
Houston, Texas, United States, 77094
- Active, not recruiting
- Houston Methodist West Hospital
-
Richardson, Texas, United States, 75080
- Recruiting
- UT Southwestern Clinical Center at Richardson/Plano
-
Principal Investigator:
- Jayanthi S. Lea
-
Contact:
- Site Public Contact
- Phone Number: 972-669-7044
- Email: Suzanne.cole@utsouthwestern.edu
-
Sugar Land, Texas, United States, 77479
- Active, not recruiting
- Houston Methodist Sugar Land Hospital
-
The Woodlands, Texas, United States, 77385
- Active, not recruiting
- Houston Methodist The Woodlands Hospital
-
-
Virginia
-
Charlottesville, Virginia, United States, 22908
- Recruiting
- University of Virginia Cancer Center
-
Contact:
- Site Public Contact
- Phone Number: 434-243-6303
- Email: uvacancertrials@hscmail.mcc.virginia.edu
-
Principal Investigator:
- Kari L. Ring
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Histologically proven diagnosis of endometrial cancer based on endometrial sampling with a plan to undergo laparoscopic or robotic hysterectomy and lymphatic assessment as part of primary management. Biopsy must be performed within 90 days prior to registration
Clinical stage I endometrial cancer based on the following diagnostic workup:
- History/physical examination within 30 days prior to registration is reassuring for the absence of metastatic disease
- Age >= 18 years
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or 2
- 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
- The patient or a legally authorized representative must provide study-specific informed consent prior to study entry and, for patients treated in the United States (U.S.), authorization permitting release of personal health information
- Patients must speak English, Spanish, or Korean
Exclusion Criteria:
- Patients whom the surgeon believes is not a candidate for pelvic lymphadenectomy due to medical comorbidities or other technical challenges (i.e. morbid obesity or prior surgery)
- History of chemotherapy or immunotherapy for the treatment of endometrial cancer. Progestin-containing therapies such as megestrol, medroxyprogesterone, or levonorgestrel-containing intrauterine device (IUD) are acceptable
- History of radiation to the pelvis, groin or lower extremities, or surgery to the pelvic lymph nodes or inguinal lymph nodes
- Patients who are going to undergo another elective surgery during the same operative event as their hysterectomy (i.e., sacrocolpopexy, cholecystectomy)
Patients with severe, active co-morbidity defined as follows:
- History of patient or provider identified lower extremity lymphedema
- History of patient or provider identified chronic lower extremity swelling
- History of lower extremity or pelvic deep venous thromboembolism within 90 days of registration
- History of lower extremity cellulitis within 90 days of registration
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Arm 1 (sentinel lymph node mapping)
Patients receive ICG dye via injection and undergo sentinel lymph node mapping and excision during standard minimally invasive hysterectomy.
Lymph nodes around the uterus may be removed if the mapping and excision cannot be completed.
Successful mapping requires no additional removal of lymph nodes.
Patients also undergo imaging as clinically indicated and optional blood sample collection throughout the study.
|
Ancillary studies
Undergo blood sample collection
Other Names:
Undergo sentinel lymph node mapping
Other Names:
Undergo minimally invasive hysterectomy
Other Names:
Undergo pelvic lymphadenectomy
Other Names:
Given via injection
Other Names:
Undergo sentinel lymph node excision
Other Names:
Undergo imaging
Other Names:
|
|
Experimental: Arm 2 (sentinel lymph node mapping, pelvic lymphadenectomy)
Patients receive ICG dye via injection and undergo sentinel lymph node mapping and excision during standard minimally invasive hysterectomy.
Additional lymph nodes around the uterus are removed per standard of care.
Patients also undergo imaging as clinically indicated and optional blood sample collection throughout the study.
|
Ancillary studies
Undergo blood sample collection
Other Names:
Undergo sentinel lymph node mapping
Other Names:
Undergo minimally invasive hysterectomy
Other Names:
Undergo pelvic lymphadenectomy
Other Names:
Given via injection
Other Names:
Undergo sentinel lymph node excision
Other Names:
Undergo imaging
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incidence of patient-reported lower extremity limb dysfunction
Time Frame: From 18 months post-hysterectomy after undergoing lymphatic assessment to 39 months
|
The primary endpoint is the incidence of patient-reported lower extremity limb dysfunction at 18 months post-hysterectomy after undergoing lymphatic assessment according to a National Comprehensive Cancer Network guideline-based sentinel lymph node (SLN) mapping algorithm with or without completion of lymphadenectomy.
The primary endpoint will be assessed using the Gynecologic Cancer Lymphedema Questionnaire (GCLQ) questionnaire.
Surveys will be performed at enrollment (pre-surgery) and at 3, 6, 9, 12, and 18 months post-surgery.
Patient-reported lower extremity limb dysfunction will be defined as an increase in GCLQ symptom score of at least four (4) points from baseline at any time during the 18 months follow-up.
The primary null hypothesis will be evaluated with an intent-to-treat chi-squared test, adjusted for stratification factors.
Proportional hazards modeling will be used to generate a hazard ratio and 95% confidence limits of Arm 1 versus Arm 2.
|
From 18 months post-hysterectomy after undergoing lymphatic assessment to 39 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The incidence of lymphedema by quantifiable lower extremity limb changes
Time Frame: From enrollment and at 3, 6, 9, 12, and 18 months after surgery
|
Patients will undergo circumferential lower extremity limb measures at three locations along each leg.
Change will be estimated as measurement at baseline subtracted from measurement at follow-up.
This will be assessed in both legs separately.
|
From enrollment and at 3, 6, 9, 12, and 18 months after surgery
|
|
Rate of successful bilateral SLN identification
Time Frame: At time of surgery
|
Will be assessed in both, and only as the time of surgery.
|
At time of surgery
|
|
Rate of successful identification of lymph node metastasis
Time Frame: At time of surgery
|
Will be assessed in both, and only as the time of surgery.
The rate of lymph node metastasis identification during surgery will be compared between groups, with either t-tests or chi-squared tests where appropriate.
|
At time of surgery
|
|
Rate of perioperative complications
Time Frame: At time of surgery
|
Will be assessed in both arms separately, and only as the time of surgery.
The rate of perioperative complications during surgery will be compared between groups, with either t-tests or chi-squared tests where appropriate.
|
At time of surgery
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Adjuvant therapy decisions
Time Frame: Up to 24 months
|
Adjuvant therapy decisions will be compared for patients according to study arm allocation after accounting for tumor characteristics, stage, and patient demographics to determine whether lymph node mapping strategies was associated with a difference in adjuvant therapy choice.
|
Up to 24 months
|
|
Progression free survival
Time Frame: The duration of time from study entry to time of progression or death, whichever occurs first, or date of last contact if neither progression nor death has occurred, assessed at 2 years after enrollment
|
This endpoint is not expected to be sufficiently powered for a definitive comparison and will therefore be treated as supportive evidence.
|
The duration of time from study entry to time of progression or death, whichever occurs first, or date of last contact if neither progression nor death has occurred, assessed at 2 years after enrollment
|
|
Overall survival
Time Frame: Duration of time from study entry to time of death or the date of last contact, assessed at 2 years after enrollment
|
This endpoint is not expected to be sufficiently powered for a definitive comparison and will therefore be treated as supportive evidence.
|
Duration of time from study entry to time of death or the date of last contact, assessed at 2 years after enrollment
|
|
Patient characteristic, extent of lymph node dissection, and adjuvant therapy decisions
Time Frame: Up to 24 months
|
Patient characteristics (age, body mass index, race), extent of lymph node dissection, and adjuvant therapy decisions (radiation, chemotherapy), will be collected to determine their impact as a covariate on the development of the primary endpoint (lower extremity limb dysfunction).
Models adjusting for potential confounders will be fitted and analyzed.
|
Up to 24 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Edward J Tanner, NRG Oncology
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms
- Neoplasms by Histologic Type
- Sarcoma
- Neoplasms, Connective and Soft Tissue
- Neoplasms, Complex and Mixed
- Carcinosarcoma
- Heterocyclic Compounds
- Heterocyclic Compounds, 2-Ring
- Heterocyclic Compounds, Fused-Ring
- Investigative Techniques
- Clinical Laboratory Techniques
- Diagnostic Techniques and Procedures
- Diagnosis
- Surgical Procedures, Operative
- Cytological Techniques
- Cytodiagnosis
- Physical Phenomena
- Indoles
- Diagnostic Techniques, Surgical
- Electromagnetic Phenomena
- Magnetic Phenomena
- Electromagnetic Radiation
- Radiation
- Radiation, Ionizing
- Biopsy
- Specimen Handling
- Minimally Invasive Surgical Procedures
- X-Rays
- Indocyanine Green
Other Study ID Numbers
- NRG-CC010 (Other Identifier: CTEP)
- UG1CA189867 (U.S. NIH Grant/Contract)
- NCI-2022-05090 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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National Cancer Institute (NCI)CompletedEndometrial Clear Cell Adenocarcinoma | Endometrial Mixed Cell Adenocarcinoma | Endometrial Serous Adenocarcinoma | Endometrial Adenosquamous Carcinoma | Uterine Corpus Carcinosarcoma | Metastatic Endometrioid Adenocarcinoma | Recurrent Malignant Uterine Corpus Neoplasm | Stage IVA Uterine Corpus... and other conditionsUnited States, Canada
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City of Hope Medical CenterNational Cancer Institute (NCI)CompletedStage IV Prostate Cancer AJCC v8 | Hepatobiliary Neoplasm | Stage III Renal Cell Cancer AJCC v8 | Stage IV Renal Cell Cancer AJCC v8 | Stage III Uterine Corpus Cancer AJCC v8 | Stage IV Uterine Corpus Cancer AJCC v8 | Stage IVA Uterine Corpus Cancer AJCC v8 | Stage IVB Uterine Corpus Cancer AJCC v8 | Malignant Neoplasm and other conditionsUnited States
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University of Southern CaliforniaNational Cancer Institute (NCI)RecruitingMalignant Solid Neoplasm | Hodgkin Lymphoma | Anatomic Stage I Breast Cancer AJCC v8 | Anatomic Stage IA Breast Cancer AJCC v8 | Anatomic Stage IB Breast Cancer AJCC v8 | Anatomic Stage II Breast Cancer AJCC v8 | Anatomic Stage IIA Breast Cancer AJCC v8 | Anatomic Stage IIB Breast Cancer AJCC v8 | Anatomic... and other conditionsUnited States
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M.D. Anderson Cancer CenterRecruitingChondrosarcoma | Advanced Malignant Solid Neoplasm | Stage III Uterine Corpus Cancer AJCC v8 | Stage IV Uterine Corpus Cancer AJCC v8 | Stage IVA Uterine Corpus Cancer AJCC v8 | Stage IVB Uterine Corpus Cancer AJCC v8 | Clinical Stage III Cutaneous Melanoma AJCC v8 | Pathologic Stage IIIB Cutaneous... and other conditionsUnited States
Clinical Trials on Questionnaire Administration
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Fondazione Don Carlo Gnocchi OnlusCompleted
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Centre Oscar LambretCentre Hospitalier Universitaire de BesanconTerminated
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Istanbul Aydın UniversityCompleted
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Rutgers, The State University of New JerseyNational Cancer Institute (NCI)TerminatedHealth Status UnknownUnited States
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI)CompletedBreast Carcinoma | Fallopian Tube Carcinoma | Endometrial Carcinoma | Ovarian Carcinoma | Primary Peritoneal Carcinoma | Deleterious CDH1 Gene Mutation | Deleterious DICER1 Gene Mutation | Deleterious SMARCA4 Gene Mutation | Deleterious STK11 Gene MutationUnited States
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Université Catholique de LouvainRecruiting
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M.D. Anderson Cancer CenterRecruitingHematopoietic and Lymphoid Cell Neoplasm | Malignant Solid NeoplasmUnited States
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI)RecruitingCOVID-19 InfectionUnited States
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingEndometrial Carcinoma | Malignant Uterine Neoplasm | Uterine Corpus Cancer | Uterine Corpus SarcomaUnited States
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Ohio State University Comprehensive Cancer CenterNational Center for Complementary and Integrative Health (NCCIH)CompletedBreast Cancer | Prostate CancerUnited States