Epithelioid Haemangioendothelioma Observational Study

NCT06680401 | Recruiting

• 1 other identifier: POEM
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The EHE observational study was developed to obtain a high number of datas such as clinical presentation, natural history, and treatment outcomes, cto identificate cytokines and hormones as biomarkers and generate patient-derived preclinical models as a tool to assess the activity of anticancer agents and validate novel therapeutic targets

Conditions

Natural History; Treatment Outcomes; Clinical Presentation

Outcome Measures

Primary Outcomes (8)

• Demographic description

  To provide a demographic description of the population affected by advanced EHE

  Through study completion, an average of 1 year

• Patient status

  To provide a description of clinical presentation, natural history, and treatment pattern in patients with advanced EHE

  Through study completion, an average of 1 year

• Tumor-related symptoms

  To provide a description of tumour-related symptoms and their changes over time

  Through study completion, an average of 1 year

• Tumor-related pain

  To provide a tumor-related pain assessment

  Through study completion, an average of 1 year

• Clinical prognosis

  To prospectively identify clinical prognostic and predictive factors

  Through study completion, an average of 1 year

• radiological features

  To describe the radiological features of the disease (group A, B, C, D, E)

  Through study completion, an average of 1 year

• correlation between radiological features and outcome

  To correlate radiologic features with the outcome and the tested plasma levels of the cytokines and hormones (group A, B, C, D, E)

  Through study completion, an average of 1 year

• radiological response and systemic treatment

  To assess radiologic response to systemic treatments by basing on RECIST 1.1 assessment (group B, D).

  Through study completion, an average of 1 year

Study Arms (5)

Group A

Patients newly diagnosed with advanced EE starting active surveillance

Group B

Patients with new diagnosis of advanced, evolving EE, worthy of medical treatment

Group C

Patients with a previous diagnosis of advanced EE, already under active surveillance

Group D

Patients with a previous diagnosis of advanced EE with ongoing medical treatment

Group E

Patients with localized EHE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

We plan to include at least 50 patients (range: 50-70) in 36 months, followed by a follow up time of 3 years.68 including The Royal Marsden Hospital.

You may qualify if:

• Histological diagnosis of EHE according to 2020 WHO classification, performed on biopsy or surgical specimen
• Signed informed consent
• Adequate patient compliance to treatment or follow up
• No age limit

You may not qualify if:

• Impossibility to ensure adequate compliance

Sponsors & Collaborators

• Fondazione IRCCS Istituto Nazionale dei Tumori, Milano: lead

Study Sites (1)

Fondazione IRCCS IstitutoNazionale dei Tumori

Milan, 20133, Italy

RECRUITING

Related Publications (24)

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Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood Tissue

Study Officials

• Silvia Stacchiotti

  Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Silvia Stacchiotti

CONTACT

0223902803; Silvia.Stacchiotti@istitutotumori.mi.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2024
• First Posted: November 8, 2024
• Study Start: February 25, 2021
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: April 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)