Radical Trachelectomy for Women With Early Stage Cervical Cancer

January 22, 2020 updated by: M.D. Anderson Cancer Center

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Before Surgery:

If you agree to take part in this study, before you have the abdominal radical trachelectomy surgery, the following information will be recorded during one of your regular clinic visits:

  • Your race and date of birth.
  • Your complete medical and surgical history, including the date of your diagnosis and your diagnosis before surgery.
  • Your weight, height, and body mass index.

During and After Surgery:

During and after surgery, the following information will be gathered from your medical record or you will be asked:

  • If there was any blood loss during surgery.
  • How long the surgery lasted.
  • If there were any complications during the surgery.
  • If you needed any blood transfusions.
  • What type of instrument was used for preventing or sealing blood loss.
  • How long you stayed in the hospital.
  • If you experienced any infections within 1 month after surgery.
  • If you experienced any complications within 1 month or later than 1 month after surgery.
  • The length of time it took to recover your bowel and urinary function.
  • If you received any treatments for cancer after surgery, such as radiation therapy, chemotherapy, or hormonal therapy.

Once a year for up to 5 years, if you return for an annual routine follow up visit, the results of any pap smears you have had will be collected.

Once a year for up to 5 years, you will also be asked the following questions about your health and fertility, either by mail or during a regular clinic visit:

  • What is the status of the disease?
  • Did you want to get pregnant in the last year?
  • Did you attempt to get pregnant?
  • Did you become pregnant? If so, how you became pregnant and the outcome of the pregnancy? If not how long did you try to become pregnant and did you try any form of assisted reproduction?

Questionnaires:

You will complete 4-5 questionnaires at each of the following times:

  • Within 2 weeks before your surgery.
  • At 4-6 weeks after surgery
  • At 6 months after surgery.
  • At 1 year after surgery.
  • Once a year for the next 4 years.

These questionnaires will ask about your physical health, mental and emotional health, pain, vitality, social functioning, general health, quality of life, and sexual functioning. It will take about 15 minutes to complete 5 questionnaires. If you do not receive your follow-up care at MD Anderson, the questionnaires will be mailed to you at the above time-points with a prepaid return envelope. Mailed questionnaires will be returned to the study chair in an envelope marked CONFIDENTIAL with NO RETURN ADDRESS on the return envelope. Your name will not appear on the questionnaires or return envelope. Instead, a code will be used (on the questionnaires only) that will connect the questionnaires with your medical record. Only the study chair or study coordinator will have access to the code document. The document is kept in a locked filing cabinet and/or password protected computer. All responses will be stored in a locked office.

Length of Study:

You will be on study for up to 5 years. If the disease returns, you will be taken off study.

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • University of Texas MD Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Questionnaire
Radical trachelectomy outcomes for cervical cancer
Behavioral: Questionnaires
5 Questionnaires at differing times before and after surgery.
Other Names:
  • Survey

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean scores for the General Health-Related Quality of Life (SF-12)
Time Frame: Follow up visits annually
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 16, 2008

Primary Completion (ANTICIPATED)

December 31, 2020

Study Completion (ANTICIPATED)

December 31, 2020

Study Registration Dates

First Submitted

December 18, 2008

First Submitted That Met QC Criteria

December 19, 2008

First Posted (ESTIMATE)

December 22, 2008

Study Record Updates

Last Update Posted (ACTUAL)

January 23, 2020

Last Update Submitted That Met QC Criteria

January 22, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2007-0723

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.

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