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Endometrial CancerITCMicroUtCaNCT04403867

The Role of Micrometastasis and Isolated Tumor Cells (ITCs) in Endometrial and Cervical Cancer. A Multicenter Study.

An observational study of Endometrial Cancer and Cervical Cancer, run by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano at 1 site in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The role of small-volume lymph node disease (ITC and micro metastases) among patients with endometrial or cervical cancer submitted to sentinel node (SLN) procedure is not clearly defined. This study was designed to create a dataset of patients with lymph nodal disease. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Sentinel lymph node (SLN) biosy +/- lymphadenectomy
Type of treatment
Surgery or procedure
How many people
500 participants
Where
1 siteItaly
Study dates
2 Jan 2020to Jan 2027
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 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with early stage uterine (endometrial or cervical) cancer, who underwent a sentinel lymph node (SLN) procedure with an identification of lymph nodes metastasis (macrometastasis or low volume disease [micrometastasis and isolated tumor cells])

Who may be able to join

  • Early stage endometrial cancer scheduled for SLN procedure
  • Early stage cervical cancer scheduled for SLN procedure
  • Pathological evaluation of SLNs with standard ultra-staging or one-step nucleic acid amplification (OSNA) for the detection of metastasis
  • Presence of lymph nodes metastasis (macrometastasis or low volume disease [micrometastasis and isolated tumor cells])

Who cannot join

  • Previous (<5 years) or concomitant malignancy other than non-melanoma skin cancer
  • Advanced/metastatic endometrial cancer
  • Locally advanced/metastatic cervical cancer

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Fabio Martinelli, MD contact

+390223903322

fabio.martinelli@istitutotumori.mi.it

Italy1 site, 1 recruiting

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan, 20133

    Fabio Martinelli, MD, +390223903322, fabio.martinelli@istitutotumori.mi.it

    Recruiting

Other trials in Italy

About this study

Official title: The Role of Micrometastasis and Isolated Tumor Cells (ITCs) in Uterine Cancers (Endometrial/Cervical) Submitted to Sentinel Lymph Nodes (SLN) Procedure: an Observational Study

The role of small-volume lymph node disease (ITC and micro metastases) among patients with endometrial or cervical cancer submitted to sentinel node (SLN) procedure is not clearly defined.

This study was designed to create a dataset of patients with lymph nodal disease. Data on type and volume of lymph nodal disease, therapeutic choices and oncological outcomes (DFS, OS, recurrence rate) will be collected and analyzed.

This will allow to define the groups of patients who may need or for whom it can be avoided any adjuvant treatment on the basis of lymph node status.

Being tested
Sentinel lymph node (SLN) biosy +/- lymphadenectomy
Keywords
endometrial cancer, cervical cancer, sentinel lymph node, low volume disease, survival, recurrence rate, adjuvant therapy, micrometastases, isolated tumor cell, macrometastases, ultrastaging, one-step nucleic acid amplification (OSNA)
Medical subject headings
Endometrial Neoplasms, Uterine Cervical Neoplasms, Neoplasm Micrometastasis, Lymphatic Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sentinel lymph node (SLN) biosy +/- lymphadenectomyProcedure or surgery

    Also called Pathological evaluation of lymph nodes (standard H&H + ultrastaging or OSNA)

    Evaluation of type and volume of lymph nodal disease

Study groups in NCT04403867
Study groupRoleWhat they receive
Endometrial cancer patientsPatients submitted to Sentinel Lymph Node (SLN) procedure. Patients with lymph nodal disease (macrometastasis, micrometastasis, isolated tumor cells).
Receives: Procedure: Sentinel lymph node (SLN) biosy +/- lymphadenectomy
Cervical cancer patientsPatients submitted to Sentinel Lymph Node (SLN) procedure. Patients with lymph nodal disease (macrometastasis, micrometastasis, isolated tumor cells).
Receives: Procedure: Sentinel lymph node (SLN) biosy +/- lymphadenectomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Survival (Disease free survival [DFS], overall survival [OS])

    Evaluation of survival outcomes according to the type and volume of lymph nodal disease

    Measured: through study completion, an average of 3 years

  2. Recurrence rate

    Evaluation of incidence of recurrences (number of patients having a recurrence) according to the type and volume of lymph nodal disease

    Measured: through study completion, an average of 3 year

Secondary outcomes (1)

  1. Usage of adjuvant therapy in case of small-volume lymph node disease

    Evaluation of the number of patients receiving or not receiving an adjuvant treatment (radiation therapy, chemotherapy, combinations of the two) in case of small-volume lymph node disease (ITC and micro metastasis)

    Measured: through study completion, an average of 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 May 2020
  2. Study start2 Jan 2020
  3. Primary completionJan 2025 (estimated)
  4. Study completionJan 2027 (estimated)

Resources

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
Retrospective
Enrolment
500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04403867
Sponsor's protocol ID
INT 135/19
Acronym
ITCMicroUtCa
Status last verified
Aug 2022
First submitted
18 May 2020
Last updated
17 Aug 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Gomez-Hidalgo NR, Ramirez PT, Ngo B, Perez-Hoyos S, Coreas N, Sanchez-Iglesias JL, Cabrera S, Franco S, Benavente AP, Gil-Moreno A. Oncologic impact of micrometastases or isolated tumor cells in sentinel lymph nodes of patients with endometrial cancer: a meta-analysis. Clin Transl Oncol. 2020 Aug;22(8):1272-1279. doi: 10.1007/s12094-019-02249-x. Epub 2019 Dec 20.

    PubMed 31863354

  • Ignatov A, Lebius C, Ignatov T, Ivros S, Knueppel R, Papathemelis T, Ortmann O, Eggemann H. Lymph node micrometastases and outcome of endometrial cancer. Gynecol Oncol. 2019 Sep;154(3):475-479. doi: 10.1016/j.ygyno.2019.07.018. Epub 2019 Jul 22.

    PubMed 31345606

  • Piedimonte S, Richer L, Souhami L, Arseneau J, Fu L, Gilbert L, Alfieri J, Jardon K, Zeng XZ. Clinical significance of isolated tumor cells and micrometastasis in low-grade, stage I endometrial cancer. J Surg Oncol. 2018 Dec;118(7):1194-1198. doi: 10.1002/jso.25259. Epub 2018 Oct 24.

    PubMed 30353577

  • Plante M, Stanleigh J, Renaud MC, Sebastianelli A, Grondin K, Gregoire J. Isolated tumor cells identified by sentinel lymph node mapping in endometrial cancer: Does adjuvant treatment matter? Gynecol Oncol. 2017 Aug;146(2):240-246. doi: 10.1016/j.ygyno.2017.05.024. Epub 2017 May 31.

    PubMed 28577885

  • Goebel EA, St Laurent JD, Nucci MR, Feltmate CM. Retrospective detection of isolated tumor cells by immunohistochemistry in sentinel lymph node biopsy performed for endometrial carcinoma: is there clinical significance? Int J Gynecol Cancer. 2020 Mar;30(3):291-298. doi: 10.1136/ijgc-2019-000934. Epub 2019 Dec 8.

    PubMed 31818860

  • Aloisi A, Casanova JM, Tseng JH, Seader KA, Nguyen NT, Alektiar KM, Makker V, Chiang S, Soslow RA, Leitao MM Jr, Abu-Rustum NR. Patterns of FIRST recurrence of stage IIIC1 endometrial cancer with no PARAAORTIC nodal assessment. Gynecol Oncol. 2018 Dec;151(3):395-400. doi: 10.1016/j.ygyno.2018.09.021. Epub 2018 Oct 2.

    PubMed 30286945

  • Nica A, Gien LT, Ferguson SE, Covens A. Does small volume metastatic lymph node disease affect long-term prognosis in early cervical cancer? Int J Gynecol Cancer. 2020 Mar;30(3):285-290. doi: 10.1136/ijgc-2019-000928. Epub 2019 Dec 22.

    PubMed 31871114

  • Delomenie M, Bonsang-Kitzis H, Bats AS, Ngo C, Balaya V, Xuan HTN, Koual M, Mathevet P, Lecuru F. The clinical implication of lymph nodes micrometastases and isolated tumor cells in patients with cervical cancer: A systematic review. Eur J Obstet Gynecol Reprod Biol. 2019 Oct;241:71-76. doi: 10.1016/j.ejogrb.2019.08.010. Epub 2019 Aug 19.

    PubMed 31450214

  • Guani B, Dorez M, Magaud L, Buenerd A, Lecuru F, Mathevet P. Impact of micrometastasis or isolated tumor cells on recurrence and survival in patients with early cervical cancer: SENTICOL Trial. Int J Gynecol Cancer. 2019 Mar;29(3):447-452. doi: 10.1136/ijgc-2018-000089. Epub 2019 Jan 4.

    PubMed 30833435

  • Cibula D, Abu-Rustum NR, Dusek L, Zikan M, Zaal A, Sevcik L, Kenter GG, Querleu D, Jach R, Bats AS, Dyduch G, Graf P, Klat J, Lacheta J, Meijer CJ, Mery E, Verheijen R, Zweemer RP. Prognostic significance of low volume sentinel lymph node disease in early-stage cervical cancer. Gynecol Oncol. 2012 Mar;124(3):496-501. doi: 10.1016/j.ygyno.2011.11.037. Epub 2011 Nov 25.

    PubMed 22120175

  • Cibula D, McCluggage WG. Sentinel lymph node (SLN) concept in cervical cancer: Current limitations and unanswered questions. Gynecol Oncol. 2019 Jan;152(1):202-207. doi: 10.1016/j.ygyno.2018.10.007. Epub 2018 Oct 11.

    PubMed 30318103

Questions about this trial

What is this clinical trial studying?

An observational study of Endometrial Cancer and Cervical Cancer, run by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano at 1 site in Italy.

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 4 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 17 Aug 2022. 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 Italy. 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?

Contact Fabio Martinelli, MD (+390223903322, fabio.martinelli@istitutotumori.mi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Survival (Disease free survival [DFS], overall survival [OS]) (time frame: through study completion, an average of 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04403867, which also lists 11 linked publications.

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 17 Aug 2022.

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