- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00512551
DNA Array Analysis of Patients With Cervical Cancer
A Pilot Study of Early Changes in DNA Array Expression Following Chemo-Radiation Treatment of Cervical Cancer
Study Overview
Detailed Description
Patients in this study are already scheduled to begin radiation therapy. Researchers will get tumor cells by taking two biopsies of the cervix. The first biopsy of the cervical tumor will be done before any treatment is given. The second biopsy will be performed about 48 hours after the radiation treatment has begun. They will then study the cells in the lab with a new technique for studying gene expression called DNA array, as well as human papillomavirus (HPV) analysis, quantification of apoptosis levels, hematoxylin and eosin staining, and storage of tissue for future research.
The patterns of gene expression in the biopsies will be compared with the success of radiation treatments.
Some of the material will also be stored and used in the future for other research projects.
This is an investigational study. A total of 18 patients will take part in this study. All will be enrolled at UTMDACC.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- University of Texas MD Anderson Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Newly diagnosed cervical cancer: clinical Stage IB -IIIB
- Invasive pure squamous cell carcinoma
- Planned treatment with concurrent cisplatinum/5-fluorouracil chemotherapy and pelvic radiation
Exclusion Criteria:
1. Previous cervical cancer treatment including but not limited to transvaginal cone irradiation
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Cervical cancer tumor biopsy + radiation therapy
Cervical cancer tumor biopsy + radiation therapy.
|
Biopsies of the cervical tumor performed first before any treatment is given, and the second about 48 hours after radiation treatment has began.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The goal of this clinical research study is to find out if the expression of certain genes is linked with the response of cervical cancer to radiation.
Time Frame: 8 Years
|
8 Years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Researchers will study a large number of genes located in tumor material to learn this information.
Time Frame: 8 Years
|
8 Years
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
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
Other Study ID Numbers
- IDP00-075
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 Cervical Cancer
-
University of California, San DiegoWithdrawnCervical Cancer | Cervical Cancer Stage | Cervical Cancer Stage IB2 | Cervical Cancer Stage IB1 | Cervical Cancer Stage I | Cervical Cancer Stage IB | Cervical Cancer Stage II | Cervical Cancer Stage IIa | Cervical Cancer, Stage IIB | Cervical Cancer, Stage III | Cervical Cancer Stage IIIB | Cervical Cancer... and other conditionsUnited States
-
M.D. Anderson Cancer CenterWithdrawnStage IB3 Cervical Cancer FIGO 2018 | Stage II Cervical Cancer FIGO 2018 | Stage IIA Cervical Cancer FIGO 2018 | Stage IIA1 Cervical Cancer FIGO 2018 | Stage IIA2 Cervical Cancer FIGO 2018 | Stage IIB Cervical Cancer FIGO 2018 | Stage III Cervical Cancer FIGO 2018 | Stage IIIA Cervical Cancer FIGO... and other conditions
-
Abramson Cancer Center of the University of PennsylvaniaWithdrawnCervical Cancer | Stage IB Cervical Cancer | Stage IIA Cervical Cancer | Stage IIB Cervical Cancer | Stage III Cervical Cancer | Stage IVA Cervical Cancer
-
National Cancer Institute (NCI)CompletedCervical Adenocarcinoma | Cervical Squamous Cell Carcinoma | Stage IB Cervical Cancer | Stage IIA Cervical Cancer | Stage IIB Cervical Cancer | Stage III Cervical Cancer | Stage IVA Cervical Cancer | Stage IVB Cervical CancerUnited States
-
Mayo ClinicNational Cancer Institute (NCI)RecruitingCervical Adenosquamous Carcinoma | Cervical Squamous Cell Carcinoma, Not Otherwise Specified | Recurrent Cervical Carcinoma | Stage IB3 Cervical Cancer FIGO 2018 | Stage II Cervical Cancer FIGO 2018 | Stage IIA Cervical Cancer FIGO 2018 | Stage IIA1 Cervical Cancer FIGO 2018 | Stage IIA2 Cervical... and other conditionsUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingStage IA Cervical Cancer | Stage IB Cervical Cancer | Stage IA1 Cervical Cancer | Stage IA2 Cervical Cancer | Stage IB1 Cervical Cancer | Stage IB2 Cervical Cancer | Stage IB3 Cervical CancerUnited States
-
Gynecologic Oncology GroupNational Cancer Institute (NCI)CompletedCervical Adenocarcinoma | Cervical Squamous Cell Carcinoma | Stage IB Cervical Cancer | Stage IIA Cervical Cancer | Stage IIB Cervical Cancer | Stage III Cervical Cancer | Stage IVA Cervical CancerUnited States
-
Shanghai First Maternity and Infant HospitalNot yet recruitingCervical Cancer, Stage IIB | Cervical Cancer Stage IIIB | Cervical Cancer Stage IIIA | Cervical Cancer, Stage IVA
-
University of Southern CaliforniaNational Cancer Institute (NCI)CompletedRecurrent Cervical Cancer | Stage IVA Cervical Cancer | Stage IVB Cervical Cancer | Stage IIIA Cervical Cancer | Stage IIIB Cervical CancerUnited States
-
Institut de Cancérologie de LorraineCompletedCervical Adenocarcinoma | Stage IB Cervical Cancer | Stage III Cervical Cancer | Stage II Cervical CancerFrance
Clinical Trials on Tumor Biopsies
-
National University Hospital, SingaporeUnknownNasopharyngeal Cancer | Colorectal CancerSingapore
-
Institut CurieCompletedCervical CancerFrance, Germany, Netherlands, Romania, Serbia
-
Institut CurieRecruitingCervical Cancer | Head and Neck Cancer | Ovarian Cancer | Triple-Negative Breast CancerFrance
-
Medical University of GrazRecruitingMultiple Stereotactic Tumor Biopsies During a Brain Tumor ResectionAustria
-
The Netherlands Cancer InstituteMerck Sharp & Dohme LLC; Roche Pharma AG; AstraZenecaUnknown
-
Fondazione IRCCS Ca' Granda, Ospedale Maggiore...RecruitingGlioma | Glioblastoma | Glioma Glioblastoma MultiformeItaly
-
National University Hospital, SingaporeUnknownAsian Patients With Advanced Gastro-intestinal Stromal Tumors (GIST) Treated With ImatinibSingapore
-
Amsterdam UMC, location VUmcCompletedDisseminated Malignant NeoplasmNetherlands
-
University of North Carolina, Chapel HillInterpace Diagnostics CorporationCompletedBarretts Esophagus With Dysplasia | Intramucosal AdenocarcinomaUnited States
-
Assistance Publique - Hôpitaux de ParisCompletedCrohn's DiseaseFrance