NCT00512551

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2000

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 20, 2000

Completed
7.1 years until next milestone

First Submitted

Initial submission to the registry

August 3, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 7, 2007

Completed
10.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2017

Completed
Last Updated

November 30, 2017

Status Verified

November 1, 2017

Enrollment Period

17.4 years

First QC Date

August 3, 2007

Last Update Submit

November 28, 2017

Conditions

Keywords

Cervical CancerDNA Array AnalysisGene ExpressionDNA

Outcome Measures

Primary Outcomes (1)

  • 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.

    8 Years

Secondary Outcomes (1)

  • Researchers will study a large number of genes located in tumor material to learn this information.

    8 Years

Study Arms (1)

Cervical cancer tumor biopsy + radiation therapy

Cervical cancer tumor biopsy + radiation therapy.

Procedure: Tumor Biopsies

Interventions

Biopsies of the cervical tumor performed first before any treatment is given, and the second about 48 hours after radiation treatment has began.

Cervical cancer tumor biopsy + radiation therapy

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with cervical cancer already scheduled to begin radiation therapy.

You may qualify if:

  • Newly diagnosed cervical cancer: clinical Stage IB -IIIB
  • Invasive pure squamous cell carcinoma
  • Planned treatment with concurrent cisplatinum/5-fluorouracil chemotherapy and pelvic radiation

You may not qualify if:

  • \. Previous cervical cancer treatment including but not limited to transvaginal cone irradiation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Two biopsies of the cervix will be performed to obtain tumor cells.

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Anuja Jhingran, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 3, 2007

First Posted

August 7, 2007

Study Start

June 20, 2000

Primary Completion

November 20, 2017

Study Completion

November 20, 2017

Last Updated

November 30, 2017

Record last verified: 2017-11

Locations