Cervical CancerNCT00813007
Radical Trachelectomy for Women With Early Stage 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 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- Questionnaires
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Dec 2008to 31 Dec 2020
- 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 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Study population: Women with histologically confirmed, primary adenocarcinoma, squamous cell carcinoma or adenosquamous carcinoma of the uterine cervix.
Who may be able to join
- 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
Who cannot join
- 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
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
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.
Read the 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.
- Conditions
- Cervical Cancer
- Being tested
- Questionnaires
- Keywords
- Cervical Cancer, Cervix, Questionnaire, Adenocarcinoma of uterine cervix, Squamous cell carcinoma of uterine cervix, Adenosquamous carcinoma of uterine cervix, Abdominal radical trachelectomy, Trachelectomy, Quality of life, Sexual functioning
- 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.
QuestionnairesBehavioural
Also called Survey
5 Questionnaires at differing times before and after surgery.
| Study group | Role | What they receive |
|---|---|---|
| Questionnaire | Radical trachelectomy outcomes for cervical cancer Receives: Behavioral: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Follow up visits annually
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2008 (estimated)
- Study start16 Dec 2008
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael M. Frumovitz, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00813007
- Sponsor's protocol ID
- 2007-0723
- Status last verified
- Jan 2020
- First submitted
- 18 Dec 2008
- Last updated
- 23 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radical Trachelectomy for Women With Early Stage Cervical Cancer
- ClinicalTrials.gov ID
- NCT00813007
- Acronym / sponsor ID
- 2007-0723
- Conditions
- Cervical Cancer
- Keywords
- Cervical Cancer, Cervix, Questionnaire, Adenocarcinoma of uterine cervix, Squamous cell carcinoma of uterine cervix, Adenosquamous carcinoma of uterine cervix, Abdominal radical trachelectomy, Trachelectomy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 16 Dec 2008 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 22 Dec 2008 (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 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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Questionnaire | – | Behavioral: QuestionnairesRadical trachelectomy outcomes for cervical cancer |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women with histologically confirmed, primary adenocarcinoma, squamous cell carcinoma or adenosquamous carcinoma of the uterine cervix.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| QuestionnairesAlso: Survey5 Questionnaires at differing times before and after surgery. | Behavioural | Questionnaire |
Primary outcome
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2020.
- University of Texas MD Anderson Cancer Center WebsiteLink 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.
Michael M. Frumovitz, 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 7 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 23 Jan 2020. 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?
Results are not available in the source record.
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?
Mean scores for the General Health-Related Quality of Life (SF-12) (time frame: Follow up visits annually). 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 23 Jan 2020.