Examining factors affecting treatment response in gastroenteropancreatic neuroendocrine tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study investigates how various tumor and patient-related factors influence the response to medical treatments in patients with well-differentiated gastroenteropancreatic neuroendocrine neoplasms (GEP-NENs). It involves a retrospective analysis of data collected from multiple centers, focusing on progression-free survival as the primary outcome. Additionally, a subgroup of patients will undergo transcriptome analysis to identify potential biomarkers that may predict treatment responses. The study aims to clarify the relationship between clinical variables and tumor behavior under treatment.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age \>= 18
* Well-differentiated, localized (but not suitable for surgical treatment) or advanced (locally or with distant metastasis) GEP-NENs
* availability of data on site of primary tumor, stage of the, date of diagnosis
* treated with one (or more) of the following therapies:

  * Somatostatin analogs

    * G1 or G2 (Ki67 \<10%) GEP-NENs
    * Treated for at least 6 months
    * first-line therapy (or as second-line after surgery in patients with residual disease or recurrence after surgical resection)
  * Sunitinib/Everolimus

    * G1/G2 GEP-NENs
    * Treated for at least 6 months
    * first- or second-line therapy
  * Capecitabine-Temozolomide (CAP-TEM)

    * G2 or G3 (Ki67 \< 55%) GEP-NENs
    * first-, second-, or third-line therapy
    * Treated for at least 6 months

Exclusion Criteria:

* Age \< 18aa
* Patients concomitantly treated with loco-regional treatments
* Patients previously treated with radioligand therapy
* Patients with need of CAP-TEM dose reduction of more than 33% for at least 3 administrations
* NENs of unknown primitivity (including patients with biopsy on secondary lesion compatible with metastasis from GEP-NEN, but with occult primary neoplasm)
* Patients with Mixed NENs (MiNENs)
* Patients with poorly differentiated neuroendocrine carcinoma
* Pregnancy and breastfeeding

Where it's running

• IRCCS OSpedale San Raffaele
  Milan, Italy Recruiting

Study contacts

• Principal investigator: Gabriele Capurso, PhD — IRCCS Ospedale San Raffaele
• Study coordinator: Matteo Tacelli, PhD
• Email: tacelli.matteo@hsr.it
• Phone: 0226435507

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.