Observational Study of Women With Endometrial Cancer Who Receive the Standard Treatment for Their Disease

  • STATUS
    Recruiting
  • participants needed
    1400
  • sponsor
    Memorial Sloan Kettering Cancer Center
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Updated on 19 February 2024
See if I qualify
cancer
hysterectomy
metastasis
adenocarcinoma
endometrioid carcinoma
skin cancer
positron emission tomography
lymphedema
skin carcinoma
dilation and curettage
abdomen ct
adjuvant
melanoma
endometrial cancer

Summary

This study is being done to find out how often endometrial cancer recurs after the standard treatment as well as how often the standard treatment results in a lymphedema.

Details
Condition Adenocarcinoma, Adenocarcinoma, Endometrial Carcinoma, Uterine Cancer, Uterine Cancer, Ovarian Cancer, Ovarian Cancer, Endometrioid carcinoma, Endometrial Cancer Stage I
Age 18-100 years
Treatment Physical exam
Clinical Study IdentifierNCT04291612
SponsorMemorial Sloan Kettering Cancer Center
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

Patients will be classified in the study cohort (part 2; n=182) according to
surgical treatment received, final post hysterectomy and staging pathologic
report, and planned adjuvant treatment. The inclusion criteria are specified
below
Study Cohort (part 2 n=182)
A patient will be enrolled in the study cohort (part 2) if all the following
criteria are
met
At surgery, the patient must undergo
Hysterectomy with removal of the adnexa
Bilateral pelvic SLN mapping (bilateral sentinel nodes are negative for malignancy)
On the final pathologic report, the patient must have a diagnosis of
Stage I intermediate-risk endometrial endometrioid cancer (Grade 1 or Grade 2 with 50% myometrial invasion or Grade 3 with <50% myometrial invasion)
Negative pelvic peritoneal cytology
Adjuvant treatment as recommended by the multidisciplinary team must be as follows
No adjuvant treatment, or
Intravaginal radiation only

Exclusion Criteria

There is intra-operative detection of extra-uterine disease or grossly involved lymph nodes
Presence of any positive pelvic nodes including micrometastasis and isolated tumor cells (ITC)
Hysterectomy is not performed
Failed unilateral or bilateral SLN mapping
Patient undergoes a complete unilateral or bilateral pelvic lymphadenectomy
Patient undergoes a radical type C hysterectomy
Stage IA endometrioid cancer Grade1 or 2 and myometrial invasion <50%
Stage IB Grade 3 endometrioid cancer
Non-endometrioid histology: Serous, clear cell, carcinosarcoma, undifferentiated, or de-differentiated histology noted on final hysterectomy pathology
Empty unilateral or bilateral sentinel lymph nodal packet(s)
Positive peritoneal cytology
Clear my responses
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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cancer
hysterectomy
metastasis
adenocarcinoma
endometrioid carcinoma
skin cancer
positron emission tomography
lymphedema
skin carcinoma
dilation and curettage
abdomen ct
adjuvant
melanoma
endometrial cancer

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