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Asymptomatic Small Pancreatic Endocrine Neoplasms. (ASPEN)

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ClinicalTrials.gov Identifier: NCT03084770
Recruitment Status : Recruiting
First Posted : March 21, 2017
Last Update Posted : March 21, 2017
Sponsor:
Information provided by (Responsible Party):
Massimo Falconi, IRCCS San Raffaele

Brief Summary:

The aim of the study is to evaluate the most appropriate management of sporadic asymptomatic non-functioning pancreatic neuroendocrine neoplasms (NF-PNEN) ≤ 2 cm. P NF-PNEN management will be decided at the hospital and all therapeutics decision will be decided/coordinated by the treating physician.

Patients will be either submitted to surgical resection or to active surveillance.


Condition or disease Intervention/treatment
Non Functioning Pancreatic Endocrine Tumor Diagnostic Test: Radiological imaging studies Other: Quality of Life Assessment

Detailed Description:

In the last decade a dramatic increase in diagnosis of small, incidentally discovered, NF-PNEN was observed. Various study indicates the safety of a conservative management for this lesion and the The European Neuroendocrine Tumor Society (ENETS) proposed a "wait and see" approach for small NF-PNEN.

Indications for surgery include the presence of a localized NF-PNEN in the absence of distant metastases as curative resection of these tumors is associated with favourable prognosis especially for low grade.

In the last decade a dramatic increase in diagnosis of small, incidentally discovered, NF-PNEN was observed.Moreover, other investigators observed a clear relationship between the tumor diameter and low risk of malignancy and systemic progression.

In particular, a tumor size ≤ 2 cm seems to be associated with a negligible risk of disease recurrence and with a very low incidence of aggressive features such as lymph node involvement.On this basis, the European Neuroendocrine Tumor Society (ENETS) proposed a "wait and see" approach for small NF-PNEN when incidentally discovered. Since then, various series evaluated the safety of a conservative management for small, sporadic, incidentally diagnosed, NF-PNEN.

After a median follow-up of 28-45 months, all the studies confirmed that an intensive surveillance for incidental and small NF-PNEN is safe in selected cases.

Nevertheless, available data are based only on retrospective series with a significant heterogeneity of inclusion criteria and different tumor diameter cut-off and the appropriate management of this entities (surveillance versus surgery) is still a matter of debate.


Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Evaluation of the Management of Sporadic Asymptomatic Nonfunctioning Pancreatic Neuroendocrine Neoplasms ≤ 2 cm
Actual Study Start Date : March 1, 2017
Estimated Primary Completion Date : March 31, 2023
Estimated Study Completion Date : March 31, 2023


Group/Cohort Intervention/treatment
Active surveillance group
Advised surveillance strategy consists of imaging studies (MR or EUS or US), every 6 months for the first two years and yearly thereafter for five years in the absence of significant changes on imaging or symptoms appearance. During surveillance, a high-quality imaging technique (MRI or CT) is mandatory at least every 12 months. Determination of CgA during follow-up is at physician's discretion. During follow-up, the treating physician is responsible for patient management and decision-making.
Diagnostic Test: Radiological imaging studies
Patients will be submitted to radiological imaging studies (CT scan and/or MRI and/ or 68Gallium PET/CT and/or Octreoscan and/or EUS+FNAand/or Octreoscan and/or EUS+FNA) at diagnosis, and then every 6 months for the first two years and yearly thereafter for five years in the absence of significant changes on imaging or symptoms appearance. Every 12 months (or 6 months for patients with Ki67> 2%) a high quality imaging (CT scan or MRI) is required.

Other: Quality of Life Assessment
quality of life and the perceived burden of surveillance or follow-up after surgery for participants, will be investigated by administrating HADS questionnaire and EORTC QLQ-C30 (version 3) and EORTC QLQ-GI.NET21 Module.

Surgical resection group
Timing and type of resection will be established by the treating physician. Follow up strategy after surgery consists of imaging studies (MR or CT), every 6 months for the first two years and yearly thereafter for five years. An high-quality imaging technique (MRI or CT) is mandatory at least every 12 months. Determination of CgA during follow-up is at physician's discretion. During follow-up, the treating physician is responsible for patient management and decision-making. Date of surgery does not change the timing of follow up which starts from the date of enrolment.
Diagnostic Test: Radiological imaging studies
Patients will be submitted to radiological imaging studies (CT scan and/or MRI and/ or 68Gallium PET/CT and/or Octreoscan and/or EUS+FNAand/or Octreoscan and/or EUS+FNA) at diagnosis, and then every 6 months for the first two years and yearly thereafter for five years in the absence of significant changes on imaging or symptoms appearance. Every 12 months (or 6 months for patients with Ki67> 2%) a high quality imaging (CT scan or MRI) is required.

Other: Quality of Life Assessment
quality of life and the perceived burden of surveillance or follow-up after surgery for participants, will be investigated by administrating HADS questionnaire and EORTC QLQ-C30 (version 3) and EORTC QLQ-GI.NET21 Module.




Primary Outcome Measures :
  1. Disease/progression-free survival of NF-PNEN ≤ 2 cm [ Time Frame: From date of enrolment until the date of first documented progression or first evidence of recurrence, from 6 months up to 6 years. ]
    The primary endpoint is disease/progression-free survival, defined as the time from study enrolment to the first evidence of progression (active surveillance group) or recurrence of disease (surgical resection group) or death from disease.


Secondary Outcome Measures :
  1. Frequency of NF-PNEN ≤ 2 cm [ Time Frame: 6 years ]
    The secondary end point is to evaluate the frequency of asymptomatic sporadic NF-PNEN ≤ 2 cm among overall sporadic NF-PNEN. Participating centers are required to give yearly the number of patients with NF-PNEN referred to their institution.

  2. Outcome of surgical intervention of NF-PNEN ≤ 2 cm [ Time Frame: from the date of surgery to 1 months later the surgery ]
    Morbidity and mortality of patients submitted to surgical resection

  3. Epidemiology of patients submitted to surgical intervention for NF-PNEN ≤ 2 cm [ Time Frame: from the date of surgery, up to 6 years ]
    Number of patients submitted to surgery andh type of surgical procedures.

  4. Evolution of NF-PNEN ≤ 2 cm [ Time Frame: From date of enrolment until the date of first documented radiological evolution, from 6 months up to 6 years. ]
    NF-PNEN evolution, in terms of development of symptoms, tumour growth, development of distant metastases and secondary pancreatic duct dilatation.

  5. Quality of Life of NF-PNEN ≤ 2 cm [ Time Frame: from 6 months up to 6 years. ]
    The perceived burden of surveillance or follow-up after surgery for participants, as assessed by questionnaires regarding attitude towards surveillance and general anxiety and depression (Hospital Anxiety and Depression scale, HADS). Quality of Life will be investigated, by filling in EORTC QLQ-C30 (version 3) and EORTC QLQ-GI.NET21 Module.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with a newly diagnosis (less thn 12 months) of non- functioning pancreatic endocrine neoplasia (NF-PNEN) ≤ 2 cm of diameter. Either patients submitted to surgery or in active surveillance can be enrolled. Patients with sindrome or genetics disorders are excluded from the study.
Criteria

Inclusion Criteria:

  • Age > 18 years
  • Individuals with asymptomatic sporadic NF-PNEN ≤ 2 cm
  • Diagnosis has to be proven by a positive fine-needle aspiration (FNA) or by the presence of a measurable nodule on high-quality imaging technique (CT or MR) that is positive at 68Gallium DOTATOC-PET scan or Octreoscan.
  • Patients who undergo surgery for NF-PNEN<2cm within 12 months. In these cases, diagnosis has to be proven by histological confirmation of NF-PNEN
  • Informed consent

Exclusion Criteria:

  • NF-PNEN > 2 cm of maximum diameter
  • Presence of genetic syndrome (MEN1, VHL, NF)
  • Presence of symptoms (specific symptoms suspicious of a clinical syndrome related to hypersecretion of bioactive compounds) or unspecific symptoms

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03084770


Contacts
Contact: Massimo Falconi, Professor 0039 022643 6046 falconi.massimo@hsr.it
Contact: Stefano Partelli, MD PhD 0039 022643 7697 partelli.stefano@hsr.it

Locations
Italy
IRCCS San Raffaele Hospital Recruiting
Milan, Italy, 20132
Contact: Massimo Falconi, Professor    0039 0226436046    massimo.falconi@hsr.it   
Contact: Stefano Partelli, MD PhD    0039 02 26437697    partelli.stefano@hsr.it   
Principal Investigator: Francesca Muffatti, MD         
Sponsors and Collaborators
IRCCS San Raffaele
Investigators
Principal Investigator: Massimo Falconi, Professor IRCCS San Raffaele

Publications:

Responsible Party: Massimo Falconi, full Professor, IRCCS San Raffaele
ClinicalTrials.gov Identifier: NCT03084770     History of Changes
Other Study ID Numbers: ASPEN
First Posted: March 21, 2017    Key Record Dates
Last Update Posted: March 21, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Massimo Falconi, IRCCS San Raffaele:
NF-PNEN

Additional relevant MeSH terms:
Neoplasms
Endocrine Gland Neoplasms
Adenoma, Islet Cell
Pancreatic Neoplasms
Neoplasms by Site
Endocrine System Diseases
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Digestive System Neoplasms
Digestive System Diseases
Pancreatic Diseases