Evidence map›Paper›PMID 32699021›Full record

ArticleInternational journal of gynecological cancer : official journal of the International Gynecological Cancer Society2020

A prospective multicenter international single-arm observational study on the oncological safety of the sentinel lymph node algorithm in stage I intermediate-risk endometrial cancer (SELECT, SEntinel Lymph node Endometrial Cancer Trial).

Tommaso Grassi, Andrea Mariani, David Cibula, Pamela T Soliman, Vera J Suman, Amy L Weaver, Silvana Pedra Nobre, Britta Weigelt, Gretchen E Glaser, Serena Cappuccio and 1 more

Registry-linked trialOpen access · greenAbstract readClinical Trial Protocol
In one paragraph

Article in International journal of gynecological cancer : official journal of the International Gynecological Cancer Society, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04291612 (SEntinel Lymph Node Endometrial Cancer Trial), which is not on this map. Cited by 10 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 2 pooled it
1.8field-weighted citation impact, top 11% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04291612 recruitingnot on this map

SEntinel Lymph Node Endometrial Cancer Trial: A Prospective Multicenter International Single-Arm Observational Trial (SELECT)

TypeobservationalSponsorMemorial Sloan Kettering Cancer CenterRan2020 to 2027Enrolled1,715ConditionsEndometrial Cancer, Endometrioid Adenocarcinoma, Endometrial Cancer Stage IArmsPhysical exam
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 2 syntheses or guidelines pooled it, 30 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Article
  4. Review
  5. Sentinel node mapping in endometrial cancer.Journal of gynecologic oncology · 2024
    Review
  6. Article
  7. Article
  8. Review
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors at 6 institutions in 3 countries.

Tommaso GrassiDepartment of Obstetrics and Gynecology, Mayo Clinic, Rochester, Minnesota, USA.
Andrea MarianiDepartment of Obstetrics and Gynecology, Mayo Clinic, Rochester, Minnesota, USA.
David CibulaGynecologic Oncology Center, Department of Obstetrics and Gynecology, First Faculty of Medicine, Charles University and General University Hospital, Prague, Czech Republic.
Pamela T SolimanDepartment of Gynecologic Oncology and Reproductive Medicine, University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Vera J SumanDivision of Biomedical Statistics and Informatics, Mayo Clinic, Rochester, Minnesota, USA.
Amy L WeaverDivision of Biomedical Statistics and Informatics, Mayo Clinic, Rochester, Minnesota, USA.
Silvana Pedra NobreGynecology Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, New York, USA.
Britta WeigeltDepartment of Pathology, Memorial Sloan Kettering Cancer Center, New York, New York, USA.
Gretchen E GlaserDepartment of Obstetrics and Gynecology, Mayo Clinic, Rochester, Minnesota, USA.
Serena CappuccioDepartment of Obstetrics and Gynecology, Mayo Clinic, Rochester, Minnesota, USA.
Nadeem R Abu-RustumGynecology Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, New York, USA abu-rusn@mskcc.org.
Mayo Clinic · USMemorial Sloan Kettering Cancer Center · USCharles University · CZThe University of Texas MD Anderson Cancer Center · USUniversità Cattolica del Sacro Cuore · ITUniversity of Milano-Bicocca · IT

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Hongbiao Carl Lekaye · 1985 to 2026
$347.4M
NCI NIH HHS P30 CA008748
6 · The paper itself

Abstract

backgroundIn the primary treatment of apparent uterine-confined endometrial carcinoma, pelvic ± para-aortic lymphadenectomy has been considered the standard of care. Although some retrospective data suggest that the sentinel lymph node algorithm without complete lymphadenectomy can be used without jeopardizing oncologic outcome, prospective data are lacking. PRIMARY

objectivesTo assess the 36 month incidence of pelvic/non-vaginal recurrence in women with pathologically confirmed stage I intermediate-risk endometrioid endometrial carcinoma who have bilateral negative pelvic sentinel lymph nodes. STUDY HYPOTHESIS: We hypothesize that patients with stage I, intermediate-risk endometrioid endometrial carcinoma who have bilateral negative pelvic sentinel lymph nodes will demonstrate a pelvic/non-vaginal recurrence rate comparable to historical estimate of stage I, intermediate-risk endometrioid endometrial carcinoma patients (estimated 2.5%). TRIAL

designThis prospective multicenter single-arm observational study will follow women with stage I, intermediate risk endometrioid endometrial adenocarcinoma who have undergone successful hysterectomy, bilateral salpingo-oophorectomy, and bilateral sentinel lymph node biopsies, for recurrence. All patients will undergo lymphatic mapping using indocynanine green and will either receive no adjuvant treatment or vaginal brachytherapy only. Patients will be followed for 36 months. MAJOR INCLUSION/EXCLUSION CRITERIA: Patients will be enrolled in the study cohort if all the following criteria are met: (i) at time of surgery: hysterectomy with bilateral adnexectomy, and successful bilateral pelvic sentinel lymph node mapping; (ii) on final pathology: pathologic stage I, intermediate-risk endometrioid endometrial carcinoma (grade 1 or grade 2 with ≥50% myometrial invasion, or grade 3 with <50% myometrial invasion), negative pelvic peritoneal cytology, and bilateral sentinel lymph nodes negative for malignancy; (iii) recommended adjuvant treatment: vaginal brachytherapy or no adjuvant treatment. PRIMARY ENDPOINT: Incidence of pelvic/non-vaginal recurrence at 36 months. SAMPLE SIZE: 182 patients for study cohort ESTIMATED DATES FOR COMPLETING ACCRUAL AND PRESENTING

resultsAccrual will be completed in 2023 with results reported in 2026.

trial registrationNCT04291612.

Indexed as

AdenocarcinomaEndometrial NeoplasmsSentinel Lymph NodeSentinel Lymph Node BiopsyFemaleHumansLymphatic MetastasisMulticenter Studies as TopicNeoplasm Recurrence, LocalObservational Studies as TopicProspective Studiesendometriumsentinel lymph nodesurgical procedures, operative

Identifiers

PMID32699021
PMCPMC8223167
OpenAlexW3045360268

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.