FIGO Grade 1 Endometrial Endometrioid AdenocarcinomaNCT04604613
Prediction of Recurrence Among Low Risk Endometrial Cancer Patients
An observational study of FIGO Grade 1 Endometrial Endometrioid Adenocarcinoma and FIGO Grade 2 Endometrial Endometrioid Adenocarcinoma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
This study investigates whether molecular testing can help to predict the risk of endometrial cancer coming back (recurrence) after treatment in patients diagnosed with low risk endometrial cancer and scheduled to have surgery to remove the uterus and/or cervix (hysterectomy). Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- FIGO Grade 1 Endometrial Endometrioid Adenocarcinoma, FIGO Grade 2 Endometrial Endometrioid Adenocarcinoma
- What is being tested?
- Bilateral Salpingectomy with Oophorectomy, Biospecimen Collection and Hysterectomy
- Type of treatment
- Surgery or procedure
- How many people
- 518 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Nov 2012to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients diagnosed with low risk endometrial cancer who are scheduled to have a hysterectomy
Who may be able to join
- Histologically confirmed low grade (grade 1-2) endometrioid type adenocarcinoma
- Candidate for surgery
- No evidence of deep invasion or peritoneal disease in patients that have undergone preoperative imaging
- Patients may have had prior hormonal treatment for the treatment of early endometrial neoplasia. Patients may not have had prior radiation or chemotherapy for treatment of endometrial cancer
- Patients must have a negative pregnancy if of childbearing potential
Who cannot join
- Histologically confirmed high grade endometrioid or non-endometrioid type endometrial cancer (including serous, clear cell, carcinosarcoma or any mixed tumor containing these cell types)
- Medical co-morbidities making surgery unsafe, as determined by the primary treating physician
- Evidence of deep myometrial invasion, cervical involvement or peritoneal disease on preoperative imaging
- Prior treatment with radiation or chemotherapy for endometrial cancer
- Any contraindication to lymph node mapping
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prediction of Recurrence Among Low Risk Endometrial Cancer Population
This study investigates whether molecular testing can help to predict the risk of endometrial cancer coming back (recurrence) after treatment in patients diagnosed with low risk endometrial cancer and scheduled to have surgery to remove the uterus and/or cervix (hysterectomy). Having sentinel lymph node mapping performed may help researchers to see if the cancer has spread in patients with low risk endometrial cancer.
Read the detailed description
PRIMARY OBJECTIVE:
- Validate the use of a molecular panel of estrogen-induced genes to predict recurrence in low risk endometrial cancer.
SECONDARY OBJECTIVES:
- Calculate the positive predictive value (PPV)/negative predictive value (NPV)/sensitivity (Sens)/specificity (Spec) of lymph node mapping to predict pelvic lymph node involvement.
II. Correlate CA125 and HE4 levels with recurrence and to explore the use of other serum biomarkers to predict recurrence.
III. Describe patterns of recurrence in a low risk patient population. IV. Determine if molecular panel can predict lymph node involvement in low risk endometrial cancer patients who undergo pelvic and para-aortic lymphadenectomy.
- Compare performance of molecular panel to the Mayo low risk criteria for prediction of lymph node involvement.
VI. Compare performance of molecular panel to the high intermediate risk criteria from Gynecologic Oncology Group, trial 99 (GOG 99) for prediction of recurrence.
VII. Determine the feasibility of lymph node mapping in this patient population.
VIII. Determine the morbidity and mortality of lymph node dissection and mapping.
OUTLINE:
Patients undergo hysterectomy and sentinel lymph node mapping. Patients may also undergo bilateral salpingo-oophorectomy at the direction of the treating physician. If peritoneal disease or other contraindications to lymphatic mapping are detected at the time of surgery, mapping and sentinel node biopsy are performed at the surgeon's discretion. At the time of hysterectomy, patients undergo collection of tissue for molecular testing. Before and after surgery, patients also undergo collection of blood samples for tumor marker analysis.
- Conditions
- FIGO Grade 1 Endometrial Endometrioid Adenocarcinoma, FIGO Grade 2 Endometrial Endometrioid Adenocarcinoma
- Being tested
- Bilateral Salpingectomy with Oophorectomy, Biospecimen Collection, Hysterectomy, Laboratory Biomarker Analysis, Lymph Node Mapping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bilateral Salpingectomy with OophorectomyProcedure or surgery
Also called bilateral salpingo-oophorectomy
Undergo standard of care bilateral salpingo-oophorectomy
Biospecimen CollectionProcedure or surgery
Undergo collection of blood and tissue samples
HysterectomyProcedure or surgery
Also called Hysterectomy NOS
Undergo standard of care hysterectomy
Laboratory Biomarker AnalysisOther
Correlative studies
Lymph Node MappingProcedure or surgery
Also called lymphatic mapping
Undergo sentinel lymph node mapping
Sentinel Lymph Node BiopsyProcedure or surgery
Also called Sentinel Node Biopsy, Sentinel node biopsy alone, SLNB, SNB
Undergo sentinel lymph node biopsy
| Study group | Role | What they receive |
|---|---|---|
| Ancillary-Correlative (biospecimen collection, node mapping) | Patients undergo hysterectomy and sentinel lymph node mapping. Patients may also undergo bilateral salpingo-oophorectomy at the direction of the treating physician. If peritoneal disease or other contraindications to lymphatic mapping are detected at the time of surgery, mapping and sentinel node biopsy are performed at the surgeon's discretion. At the time of hysterectomy, patients undergo collection of tissue for molecular testing. Before and after surgery, patients also undergo collection of blood samples for tumor marker analysis. Receives: Procedure: Bilateral Salpingectomy with Oophorectomy; Procedure: Biospecimen Collection; Procedure: Hysterectomy; Other: Laboratory Biomarker Analysis; Procedure: Lymph Node Mapping; Procedure: Sentinel Lymph Node Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-year recurrence
Will validate a model's ability to predict 2-year recurrence in low-risk endometrial cancer patients.
Measured: At 2 years
Secondary outcomes (6)
Predictive ability of lymph node mapping in pelvic lymph node involvement
Will calculate the sensitivity (true positive fraction [TPF]), specificity (1-false positive fraction [FPF]), positive predictive value (PPV), and negative predictive value (NPV) of lymph node mapping in predicting pelvic lymph node involvement, along with 2-sided 95% confidence intervals.
Measured: Up to 2 years
Feasibility of lymph node mapping
Feasibility of lymph node mapping in this patient population will be determined after examining the TPF, FPF, PPV, and NPV.
Measured: Up to 2 years
Morbidity and mortality prevalence associated with lymph node dissection
Morbidity and mortality prevalence associated with lymph node dissection and mapping will be calculated with 95% confidence intervals.
Measured: Up to 2 years
Patterns of recurrence
Will determine which demographic and clinical traits are most associated with recurrence rate using proportional hazards models and with 2-year recurrence using logistic regression models. Will conduct univariate analyses using log-rank tests and Fisher's exact tests, in the case of categorical traits, and proportional hazards and logistic regression models, in the case of continuous traits. Will examine all traits for violations of the proportional hazards assumption (recurrence rate models), and will examine all continuous traits for functional form (recurrence and recurrence rate models). Will use the same methods to determine whether CA125 and HE4 is associated with recurrence and recurrence rate.
Measured: Up to 2 years
Predictive ability of molecular panel in lymph node involvement
Will use Cartesian and Regression Tree Analysis and logistic regression to determine if the molecular panel can predict lymph node involvement. Will assess the use of the model by calculating sensitivity, specificity, PPV, and NPV. Additionally, will examine how often the results of the molecular panel model concur with the Mayo low risk criteria for prediction of lymph node involvement. All agreement statistics will be presented with their 95% confidence intervals.
Measured: Up to 2 years
Predictive ability of marker panel in recurrence
Will examine how well the predictive ability of the marker panel agrees with the predictive ability of the high intermediate risk criteria from Gynecologic Oncology Group, trial 99 using this patient population. 95% confidence intervals will be calculated for all concordance statistics.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2020
- Study start8 Nov 2012
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FIGO Grade 1 Endometrial Endometrioid AdenocarcinomaStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 518 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shannon N Westin, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04604613
- Sponsor's protocol ID
- PA12-0550
- Other IDs
- NCI-2020-07548, PA12-0550
- Status last verified
- Sep 2026
- First submitted
- 21 Oct 2020
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Recurrence Among Low Risk Endometrial Cancer Population
- ClinicalTrials.gov ID
- NCT04604613
- Acronym / sponsor ID
- PA12-0550
- Conditions
- FIGO Grade 1 Endometrial Endometrioid Adenocarcinoma, FIGO Grade 2 Endometrial Endometrioid Adenocarcinoma
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 518 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 8 Nov 2012 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 27 Oct 2020 (actual)
- 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.
This study investigates whether molecular testing can help to predict the risk of endometrial cancer coming back (recurrence) after treatment in patients diagnosed with low risk endometrial cancer and scheduled to have surgery to remove the uterus and/or cervix (hysterectomy). Having sentinel lymph node mapping performed may help researchers to see if the cancer has spread in patients with low risk endometrial cancer.
Detailed description
PRIMARY OBJECTIVE:
- Validate the use of a molecular panel of estrogen-induced genes to predict recurrence in low risk endometrial cancer.
SECONDARY OBJECTIVES:
- Calculate the positive predictive value (PPV)/negative predictive value (NPV)/sensitivity (Sens)/specificity (Spec) of lymph node mapping to predict pelvic lymph node involvement.
II. Correlate CA125 and HE4 levels with recurrence and to explore the use of other serum biomarkers to predict recurrence.
III. Describe patterns of recurrence in a low risk patient population. IV. Determine if molecular panel can predict lymph node involvement in low risk endometrial cancer patients who undergo pelvic and para-aortic lymphadenectomy.
- Compare performance of molecular panel to the Mayo low risk criteria for prediction of lymph node involvement.
VI. Compare performance of molecular panel to the high intermediate risk criteria from Gynecologic Oncology Group, trial 99 (GOG 99) for prediction of recurrence.
VII. Determine the feasibility of lymph node mapping in this patient population.
VIII. Determine the morbidity and mortality of lymph node dissection and mapping.
OUTLINE:
Patients undergo hysterectomy and sentinel lymph node mapping. Patients may also undergo bilateral salpingo-oophorectomy at the direction of the treating physician. If peritoneal disease or other contraindications to lymphatic mapping are detected at the time of surgery, mapping and sentinel node biopsy are performed at the surgeon's discretion. At the time of hysterectomy, patients undergo collection of tissue for molecular testing. Before and after surgery, patients also undergo collection of blood samples for tumor marker analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ancillary-Correlative (biospecimen collection, node mapping) | – | Procedure: Bilateral Salpingectomy with Oophorectomy, Procedure: Biospecimen Collection, Procedure: Hysterectomy, Other: Laboratory Biomarker Analysis, Procedure: Lymph Node Mapping, Procedure: Sentinel Lymph Node BiopsyPatients undergo hysterectomy and sentinel lymph node mapping. Patients may also undergo bilateral salpingo-oophorectomy at the direction of the treating physician. If peritoneal disease or other contraindications to lymphatic mapping are detected at the time of surgery, mapping and sentinel node biopsy are performed at the surgeon's discretion. At the time of hysterectomy, patients undergo collection of tissue for molecular testing. Before and after surgery, patients also undergo collection of blood samples for tumor marker analysis. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients diagnosed with low risk endometrial cancer who are scheduled to have a hysterectomy
Key inclusion criteria (5 listed)
- Histologically confirmed low grade (grade 1-2) endometrioid type adenocarcinoma
- Candidate for surgery
- No evidence of deep invasion or peritoneal disease in patients that have undergone preoperative imaging
- Patients may have had prior hormonal treatment for the treatment of early endometrial neoplasia. Patients may not have had prior radiation or chemotherapy for treatment of endometrial cancer
- Patients must have a negative pregnancy if of childbearing potential
Key exclusion criteria (5 listed)
- Histologically confirmed high grade endometrioid or non-endometrioid type endometrial cancer (including serous, clear cell, carcinosarcoma or any mixed tumor containing these cell types)
- Medical co-morbidities making surgery unsafe, as determined by the primary treating physician
- Evidence of deep myometrial invasion, cervical involvement or peritoneal disease on preoperative imaging
- Prior treatment with radiation or chemotherapy for endometrial cancer
- Any contraindication to lymph node mapping
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 |
|---|---|---|
| Bilateral Salpingectomy with OophorectomyAlso: bilateral salpingo-oophorectomyUndergo standard of care bilateral salpingo-oophorectomy | Procedure or surgery | Ancillary-Correlative (biospecimen collection, node mapping) |
| Biospecimen CollectionUndergo collection of blood and tissue samples | Procedure or surgery | Ancillary-Correlative (biospecimen collection, node mapping) |
| HysterectomyAlso: Hysterectomy NOSUndergo standard of care hysterectomy | Procedure or surgery | Ancillary-Correlative (biospecimen collection, node mapping) |
| Laboratory Biomarker AnalysisCorrelative studies | Other | Ancillary-Correlative (biospecimen collection, node mapping) |
| Lymph Node MappingAlso: lymphatic mappingUndergo sentinel lymph node mapping | Procedure or surgery | Ancillary-Correlative (biospecimen collection, node mapping) |
| Sentinel Lymph Node BiopsyAlso: Sentinel Node Biopsy, Sentinel node biopsy alone, SLNB, SNBUndergo sentinel lymph node biopsy | Procedure or surgery | Ancillary-Correlative (biospecimen collection, node mapping) |
Primary outcome
2-year recurrence
Time frame: At 2 years
Will validate a model's ability to predict 2-year recurrence in low-risk endometrial cancer patients.
6 secondary outcomes
Predictive ability of lymph node mapping in pelvic lymph node involvement
Time frame: Up to 2 years
Feasibility of lymph node mapping
Time frame: Up to 2 years
Morbidity and mortality prevalence associated with lymph node dissection
Time frame: Up to 2 years
Patterns of recurrence
Time frame: Up to 2 years
Predictive ability of molecular panel in lymph node involvement
Time frame: Up to 2 years
Predictive ability of marker panel in recurrence
Time frame: Up to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- 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.
Shannon N Westin 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 FIGO Grade 1 Endometrial Endometrioid Adenocarcinoma and FIGO Grade 2 Endometrial Endometrioid Adenocarcinoma, 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 5 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 16 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
2-year recurrence (time frame: At 2 years). 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 16 Sep 2026.