Glycoprotein and Glycan in Tissue and Blood Samples of Patients With Stage IB-IVA Cervical Cancer Undergoing Surgery to Remove Pelvic and Abdominal Lymph Nodes
Glycoprotein and Glycan Profiling in Patients With Locally Advanced Cervical Cancer (Stage IB2, IIA > 4 CM, IIB to IVA) Undergoing Pelvic and Para-aortic (Abdominal) Lymphadenectomy
5 other identifiers
observational
159
1 country
18
Brief Summary
This clinical trial studies glycoprotein and glycan in tissue and blood samples of patients with stage IB-IVA cervical cancer undergoing surgery to remove pelvic and abdominal lymph nodes. Studying samples of tumor tissue and blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in deoxyribonucleic acid (DNA) and identify biomarkers related to cancer. It may also help doctors learn how far the disease has spread.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Apr 2007
Longer than P75 for all trials
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 2, 2007
CompletedFirst Submitted
Initial submission to the registry
April 11, 2007
CompletedFirst Posted
Study publicly available on registry
April 13, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 16, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
July 16, 2016
CompletedAugust 24, 2017
August 1, 2017
9.3 years
April 11, 2007
August 23, 2017
Conditions
Outcome Measures
Primary Outcomes (4)
Differences in 10 of the 300 carbohydrates under examination using the customized glycan array
Up to 3 years
Differences in approximately 50 of the 400 genes on the customized glycogene expression array
Up to 3 years
Level of immunohistochemical staining for Tn antigen and sialyl Tn antigen
Up to 3 years
Presence of T-synthase or Cosmc mutation
Up to 3 years
Secondary Outcomes (4)
Local control
Up to 3 years
Lymph node metastasis
Up to 3 years
Overall survival
Up to 3 years
Progression-free survival (recurrence and disease progression)
Up to 3 years
Study Arms (1)
Ancillary-Correlative (glycoprotein and glycan profiling)
Primary and metastatic tumor specimens are collected during lymphadenectomy and used for tissue microarray analysis, mutational analysis of T-synthase and Cosmc, immunohistochemical staining of Tn antigen and sialyl Tn antigen, and customized gene expression array analysis of 400 genes associated with glycobiology. Pre-lymphadenectomy blood is collected from patients at baseline for customized glycan array analysis of 300 carbohydrates.
Interventions
Correlative studies
Undergo lymphadenectomy
Eligibility Criteria
You may qualify if:
- Patients with primary, previously untreated, histologically confirmed locoregionally advanced (Stages IB2, IIA \> 4 cm, IIB-IVA) invasive carcinoma of the cervix (any cell type) who will undergo pelvic and para-aortic (abdominal) lymphadenectomy to determine the presence or absence of lymph node metastasis
- Patients who have met the pre-entry requirements
- Patients with a block or 25 unstained sections of formalin-fixed and paraffin-embedded primary tumor available to satisfy the primary tumor requirement
- Patients who have signed an approved informed consent and authorization permitting release of personal health information
You may not qualify if:
- Patients who do not satisfy pre-entry requirements
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gynecologic Oncology Grouplead
- National Cancer Institute (NCI)collaborator
Study Sites (18)
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California, 92868, United States
Olive View-University of California Los Angeles Medical Center
Sylmar, California, 91342, United States
Augusta University Medical Center
Augusta, Georgia, 30912, United States
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
Saint Louis University Hospital
St Louis, Missouri, 63110, United States
Sunrise Hospital and Medical Center
Las Vegas, Nevada, 89109, United States
Women's Cancer Center of Nevada
Las Vegas, Nevada, 89169, United States
Montefiore Medical Center-Einstein Campus
The Bronx, New York, 10461, United States
Summa Akron City Hospital/Cooper Cancer Center
Akron, Ohio, 44304, United States
University of Cincinnati/Barrett Cancer Center
Cincinnati, Ohio, 45219, United States
Case Western Reserve University
Cleveland, Ohio, 44106, United States
Cleveland Clinic Cancer Center/Fairview Hospital
Cleveland, Ohio, 44111, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Hillcrest Hospital Cancer Center
Mayfield Heights, Ohio, 44124, United States
Lake University Ireland Cancer Center
Mentor, Ohio, 44060, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
Oklahoma Cancer Specialists and Research Institute-Tulsa
Tulsa, Oklahoma, 74146, United States
Women and Infants Hospital
Providence, Rhode Island, 02905, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Gold
NRG Oncology
Study Design
- Study Type
- observational
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 11, 2007
First Posted
April 13, 2007
Study Start
April 2, 2007
Primary Completion
July 16, 2016
Study Completion
July 16, 2016
Last Updated
August 24, 2017
Record last verified: 2017-08