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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 16, 2008

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2020

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 18, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 19, 2008

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 22, 2008

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 23, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 22, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2007-0723

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