NCT00813007

Brief Summary

The goal of this research study is to learn about quality of life, sexual functioning, and symptoms in women who have undergone abdominal radical trachelectomy for cervical cancer. This is an investigational study. Up to 100 patients will be enrolled in this study. All will be enrolled at MD Anderson.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

December 16, 2008

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

December 18, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 22, 2008

Completed
12 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

January 23, 2020

Status Verified

January 1, 2020

Enrollment Period

12 years

First QC Date

December 18, 2008

Last Update Submit

January 22, 2020

Conditions

Cervical Cancer

Keywords

Cervical CancerCervixQuestionnaireAdenocarcinoma of uterine cervixSquamous cell carcinoma of uterine cervixAdenosquamous carcinoma of uterine cervixAbdominal radical trachelectomyTrachelectomyQuality of lifeSexual functioning

Outcome Measures

Primary Outcomes (1)

  • Mean scores for the General Health-Related Quality of Life (SF-12)

    Completed SF-12 questionnaires at baseline and at each follow-up visit (4-6 weeks, 6 months, 1 year, and annually for 4 more years)

    Follow up visits annually

Study Arms (1)

Questionnaire

Radical trachelectomy outcomes for cervical cancer

Behavioral: Questionnaires

Interventions

QuestionnairesBEHAVIORAL

5 Questionnaires at differing times before and after surgery.

Also known as: Survey
Questionnaire

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Women with histologically confirmed, primary adenocarcinoma, squamous cell carcinoma or adenosquamous carcinoma of the uterine cervix.

You may qualify if:

  • Women with histologically confirmed, primary adenocarcinoma, squamous cell carcinoma or adenosquamous carcinoma of the uterine cervix
  • Patients with FIGO stage IA1 (with lymph vascular space invasion), IA2, or IB1 disease
  • Patients must be suitable candidates for surgery
  • Patients who have signed an approved Informed Consent
  • Patients with a prior malignancy allowed if \> 3 years previous with no current evidence of disease
  • Females older than 18 years who are undergoing radical trachelectomy
  • Women must be able to read and write in either Spanish or English

You may not qualify if:

  • Any histological type other than adenocarcinoma, squamous cell carcinoma or adenosquamous carcinoma of the uterine cervix
  • Tumor size greater than 4 cm
  • FIGO stage II-IV disease
  • Patients with a history of pelvic or abdominal radiotherapy
  • Patients who are pregnant
  • Patients with contraindications to surgery
  • Patients with evidence of metastatic disease by conventional imaging studies, enlarged pelvic or aortic lymph nodes \> 2cm; or histologically positive lymph nodes

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

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Michael M. Frumovitz, 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

December 18, 2008

First Posted

December 22, 2008

Study Start

December 16, 2008

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

January 23, 2020

Record last verified: 2020-01

Locations

US(1)