NCT06656247

Brief Summary

The study aims to test on a cohort of rare patients a digital innovative tool to support patients/parents in the informed consent and assent process and to keep up-to-date a lawful informed and dynamic consent and to use samples and data for research purposes. This will favour their engagement in clinical studies, a step which is well known to be very demanding, particularly in the rare diseases scenario, and stimulate a bidirectional dialogue between researchers and patients/parents/legal representatives.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
8mo left

Started Jun 2026

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 18, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 24, 2024

Completed
1.6 years until next milestone

Study Start

First participant enrolled

June 1, 2026

Expected
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2027

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2027

Last Updated

April 22, 2026

Status Verified

April 1, 2026

Enrollment Period

8 months

First QC Date

October 18, 2024

Last Update Submit

April 21, 2026

Conditions

Rare Disorders

Keywords

Dynamic ConsentRare DiseasesDigital ToolInformed ConsentPatient Engagement

Outcome Measures

Primary Outcomes (1)

  • Test the usability of dynamic consent in a cohort of rare patients

    Collect a satisfaction questionnaire - proposed to all participating patients and carers - aiming to aim of identifying pitfalls and opportunities of this innovative consenting approach

    From platform establishment, an average of 1 year

Secondary Outcomes (1)

  • Ammeliorate the dynamic consent platform following indications received by rare patients and their carer

    After completion of primary outcome, an avaerage 2 months

Interventions

Online consentingOTHER

The design and establishment of an innovative digital tool (a software application) to implement the dynamic consent and allowing interaction among healthcare professionals and patients

Eligibility Criteria

AgeUp to 100 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All rare patients diagnosed or followed up at IRCCs istituto Ortopedico Rizzoli and Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello

You may qualify if:

  • Patients affected by a rare disease (based on clinical or genetic findings)
  • Patients with a suspect of rare disease (based on clinical or genetic findings)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • Merlec MM, Lee YK, Hong SP, In HP. A Smart Contract-Based Dynamic Consent Management System for Personal Data Usage under GDPR. Sensors (Basel). 2021 Nov 30;21(23):7994. doi: 10.3390/s21237994.

    PMID: 34883997BACKGROUND

  • Prictor M, Lewis MA, Newson AJ, Haas M, Baba S, Kim H, Kokado M, Minari J, Molnar-Gabor F, Yamamoto B, Kaye J, Teare HJA. Dynamic Consent: An Evaluation and Reporting Framework. J Empir Res Hum Res Ethics. 2020 Jul;15(3):175-186. doi: 10.1177/1556264619887073. Epub 2019 Nov 15.

    PMID: 31729900BACKGROUND

  • Dankar FK, Gergely M, Malin B, Badji R, Dankar SK, Shuaib K. Dynamic-informed consent: A potential solution for ethical dilemmas in population sequencing initiatives. Comput Struct Biotechnol J. 2020 Apr 2;18:913-921. doi: 10.1016/j.csbj.2020.03.027. eCollection 2020.

    PMID: 32346464BACKGROUND

  • Grady C. Enduring and emerging challenges of informed consent. N Engl J Med. 2015 Feb 26;372(9):855-62. doi: 10.1056/NEJMra1411250.

    PMID: 25714163BACKGROUND

  • Cocanour CS. Informed consent-It's more than a signature on a piece of paper. Am J Surg. 2017 Dec;214(6):993-997. doi: 10.1016/j.amjsurg.2017.09.015. Epub 2017 Sep 20.

    PMID: 28974311BACKGROUND

Related Links

MeSH Terms

Conditions

Rare DiseasesPatient Participation

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Central Study Contacts

Luca Sangiorgi, MD, PhD

CONTACT

(+39)051-6366342luca.sangiorgi@ior.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Rare Skeletal Diseases Department

Study Record Dates

First Submitted

October 18, 2024

First Posted

October 24, 2024

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 1, 2027

Last Updated

April 22, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share