What is this study trying to find out about neuroendocrine tumors?

This study is investigating new blood-based biomarkers, including immune markers and circular RNAs, to improve diagnosis and monitor early treatment response in neuroendocrine tumors. Researchers want to better understand how these markers change with treatment and could help in managing the disease. The University of Roma La Sapienza is leading this research to advance patient care.

Who may be eligible for this neuroendocrine tumor clinical trial?

Adults aged 18 to 80 with confirmed locally advanced or metastatic neuroendocrine tumors of the lung or gastro-entero-pancreatic tract may be eligible. Both males and females can participate. People should not have severe kidney disease, significant heart, lung, or liver problems, or other types of cancer. Please review eligibility criteria for more details.

Is there any cost to participate in this neuroendocrine tumor clinical trial?

Study-related care, including all tests and procedures, is provided at no cost to participants. However, personal travel or other expenses are not guaranteed to be covered and may vary. Participants should consider these potential costs when joining.

Actively Recruiting

Age: 18Years - 80Years

All Genders

ID04464122

Study of New Biomarkers for Diagnosis and Early Treatment Response in Pulmonary and Gastro-Entero-Pancreatic Neuroendocrine Tumors

Led by University of Roma La Sapienza · Updated on 2025-04-03

Participants Needed

Research Sites

15 weeks

Total Duration

AI-Summary

What this Trial Is About

This research aims to explore new biomarkers, including immune profiles, angiogenetic markers, and circular RNAs from tumor-educated platelets TEPs, to improve diagnosis and treatment monitoring in patients with pulmonary and gastro-entero-pancreatic neuroendocrine neoplasms NENs. NENs are diverse tumors with increasing incidence, and current markers like chromogranin A and neuron specific enolase have limited accuracy. The study focuses on better understanding the immune systems role and blood-based markers to enhance detection and follow-up of these tumors. The study involves two groups patients aged 18 to 80 with confirmed advanced or metastatic NENs from the lung or gastrointestinal tract, who will receive first-line medical treatments including somatostatin analogs or chemotherapy as recommended by clinical guidelines and a control group of similar age with non-malignant endocrine diseases. Researchers will collect samples at baseline, and after 1 and 3 months of treatment to evaluate changes in biomarkers and immune cell populations. Participants will undergo assessments of angiogenetic mediators, circular RNA levels, immune cell subpopulations, classical neuroendocrine markers, infectious disease occurrences, and quality of life questionnaires at scheduled intervals. The primary outcome is to measure changes in the angiogenetic mediator sTie2 after treatment. The study will provide detailed monitoring of these markers to understand their roles in disease progression and treatment response over several months.

CONDITIONS

Brief Title

Rediscovering Biomarkers for the Diagnosis and Early Treatment Response in NEN (REBORN)

Who Can Participate

Age: 18Years - 80Years

All Genders

Eligibility Criteria

You may qualify if you...

Histologically-proven neuroendocrine neoplasms, locally advanced or metastatic, from pulmonary or gastro-entero-pancreatic tract, candidates for first line medical therapy
Patients with other non-malignant endocrine diseases, such as benign thyroid dysfunction

You will not qualify if you...

Severe chronic kidney disease (stage 4 or 5)
Clinical or laboratory signs of significant respiratory, heart, or liver disease
Presence of other non-neuroendocrine cancers or malignancies

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Monitoring

Duration - Baseline

Participants provide baseline blood samples and clinical assessments to evaluate immune profiling, angiogenetic markers, circular RNA sequencing, and neuroendocrine markers.

1 baseline visit (in-person)

Treatment

Duration - Up to 3 months

Participants with neuroendocrine neoplasms receive first line medical therapy with somatostatin analogs or chemotherapy as per current guidelines.

Visits at 1 month and 3 months post-treatment initiation (in-person)

Monitoring

Duration - 3 months

Participants are evaluated after 1 month and 3 months of treatment to assess changes in angiogenetic mediators, circular RNAs, immune cells, classical markers, infectious disease frequency, and quality of life.

2 follow-up visits (in-person) at 1 and 3 months after treatment start