Prospective Study Assessing Emotional, Sexual and Quality of Life Concerns Of Women Undergoing Removal of the Cervix Versus Removal of the Uterus,Ovaries and Fallopian Tubes For Treatment Of Early Stage Cervical Cancer

Completed

Conditions studied: Cervical Cancer

In brief

The purpose of this study is to will help us understand how two treatments impact women with early stage cervical cancer: a radical hysterectomy, which removes the entire uterus, the ovaries, and fallopian tubes versus a radical trachelectomy which removes the cervix, which is the bottom part of the uterus. The second leaves the rest of the uterus, the ovaries, and fallopian tubes. This means that there is a chance that the woman might be able to get pregnant in the future with this type of treatment. We believe that these two operations need further study to see how they impact women. This study will look at emotions and issues of fertility. The study will also ask about quality of life and sexual functioning. What we learn from this study will help us give better information to women considering these treatments.

Key facts

Study ID

NCT00579787

Run by

Memorial Sloan Kettering Cancer Center

People needed

72

Starts

2004-01-01

Expected to finish

2010-11-01

Last updated by the study team

2010-12-02

Who can join

Age: 18 and older, up to 45. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Patients should be suitable surgical candidates and completed the surgical consenting process with their gynecologic oncology surgeon.
• Confirmed invasive cervical cancer: squamous, adeno, or adenosquamous.
• FIGO Stage IA1 with lymph-vascular space involvement or stage IA2-IB2).
• Consented for a radical trachelectomy (vaginal/abdominal) or radical hysterectomy (laparoscopic/abdominal).
• Have not started or completed childbearing.
• Strong desire to preserve fertility (trachelectomy group only).
• At least 18 years of age and not older than 45 years at the time of treatment.
• Able to read/ speak the English language.
• Able to provide informed conse

You may not qualify if…

• Inability to participate in an informed consent process.
• Patients with a psychiatric disorder precluding response to the survey.
• Patients that are upstaged at the time of surgery and will require adjuvant therapy.

Where it is running

• Memorial Sloan Kettering Cancer Center — New York, New York, United States

Full record on ClinicalTrials.gov

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