Cervical CancerNCT00512551
DNA Array Analysis of Patients With Cervical Cancer
An observational study of Cervical Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
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. Researchers will study a large number of genes located in tumor material to learn this information. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- Tumor Biopsies
- Type of treatment
- Surgery or procedure
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jun 2000to 20 Nov 2017
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with cervical cancer already scheduled to begin radiation therapy.
Who may be able to join
- Newly diagnosed cervical cancer: clinical Stage IB -IIIB
- Invasive pure squamous cell carcinoma
- Planned treatment with concurrent cisplatinum/5-fluorouracil chemotherapy and pelvic radiation
Who cannot join
- 1. Previous cervical cancer treatment including but not limited to transvaginal cone irradiation
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: A Pilot Study of Early Changes in DNA Array Expression Following Chemo-Radiation Treatment of Cervical Cancer
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. Researchers will study a large number of genes located in tumor material to learn this information.
Read the 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.
- Conditions
- Cervical Cancer
- Being tested
- Tumor Biopsies
- Keywords
- Cervical Cancer, DNA Array Analysis, Gene Expression, DNA
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tumor BiopsiesProcedure or surgery
Biopsies of the cervical tumor performed first before any treatment is given, and the second about 48 hours after radiation treatment has began.
| Study group | Role | What they receive |
|---|---|---|
| Cervical cancer tumor biopsy + radiation therapy | Cervical cancer tumor biopsy + radiation therapy. Receives: Procedure: Tumor Biopsies |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 Years
Secondary outcomes (1)
Researchers will study a large number of genes located in tumor material to learn this information.
Measured: 8 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2007 (estimated)
- Study start20 Jun 2000
- Primary completion20 Nov 2017
- Study completion20 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- 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
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anuja Jhingran, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00512551
- Sponsor's protocol ID
- IDP00-075
- Status last verified
- Nov 2017
- First submitted
- 3 Aug 2007
- Last updated
- 30 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Early Changes in DNA Array Expression Following Chemo-Radiation Treatment of Cervical Cancer
- ClinicalTrials.gov ID
- NCT00512551
- Acronym / sponsor ID
- IDP00-075
- Conditions
- Cervical Cancer
- Keywords
- Cervical Cancer, DNA Array Analysis, Gene Expression, DNA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 20 Jun 2000 (actual)
- Primary completion
- 20 Nov 2017 (actual)
- Study completion
- 20 Nov 2017 (actual)
- First posted
- 7 Aug 2007 (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.
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. Researchers will study a large number of genes located in tumor material to learn this information.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cervical cancer tumor biopsy + radiation therapy | – | Procedure: Tumor BiopsiesCervical cancer tumor biopsy + radiation therapy. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with cervical cancer already scheduled to begin radiation therapy.
Key inclusion criteria (3 listed)
- Newly diagnosed cervical cancer: clinical Stage IB -IIIB
- Invasive pure squamous cell carcinoma
- Planned treatment with concurrent cisplatinum/5-fluorouracil chemotherapy and pelvic radiation
Key exclusion criteria (1 listed)
- 1. Previous cervical cancer treatment including but not limited to transvaginal cone irradiation
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 |
|---|---|---|
| Tumor BiopsiesBiopsies of the cervical tumor performed first before any treatment is given, and the second about 48 hours after radiation treatment has began. | Procedure or surgery | Cervical cancer tumor biopsy + radiation therapy |
Primary outcome
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
1 secondary outcome
Researchers will study a large number of genes located in tumor material to learn this information.
Time frame: 8 Years
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 30 Nov 2017.
- The University of Texas M.D.Anderson Cancer CenterLink provided by the sponsor.
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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.
Anuja Jhingran, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Cancer, run by M.D. Anderson Cancer Center at 1 site 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 1 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 30 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
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). 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 30 Nov 2017.