NCT06814925

Brief Summary

It is an observational, non-interventional, prospective, monocentric study, whose objective is to enroll 1500 patients with lymphoma in 5 years within the Institute of Hematology "Seragnoli".

Trial Health

77
On Track

Trial Health Score

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

Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
3mo left

Started Dec 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
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

Study Progress95%
Dec 2021Aug 2026

Study Start

First participant enrolled

December 7, 2021

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

December 3, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 7, 2025

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Last Updated

February 7, 2025

Status Verified

October 1, 2024

Enrollment Period

4.7 years

First QC Date

December 3, 2024

Last Update Submit

February 3, 2025

Conditions

Lymphoma

Keywords

questionnaire

Outcome Measures

Primary Outcomes (1)

  • Overall Survival (OS)

    From the date of diagnosis to the date of death

    through study completion, an average of 5 years

Secondary Outcomes (12)

  • Event Free Survival (EFS)

    through study completion, an average of 5 years

  • Lymphoma Specific Survival (LSS)

    through study completion, an average of 5 years

  • Progression-Free Survival (PFS)

    through study completion, an average of 5 years

  • net survival

    through study completion, an average of 5 years

  • response rate

    through study completion, an average of 5 years

  • +7 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

1500 patients with lymphoma (about 500 cases of DLBCL, 360 of FL, 260 of CLL/SLL, 110 of MZL, 60 of PTCL e MCL, 40 of LPL/WM, 30 of MF and BL, and 15 of HCL e ALL)

You may qualify if:

  • Age greater than or equal to 18 years at enrollment
  • Diagnosis of lymphoma within 3 months of enrollment
  • Patients may have been treated, as long as the initial diagnosis of lymphoma is within 3 months of enrollment
  • Signing of the informed consent form

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Azienda Ospedaliero - Universitaria di Bologna

Bologna, Bologna, 40138, Italy

RECRUITING

MeSH Terms

Conditions

Lymphoma

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Pier Luigi Zinzani, MD

    IRCCS Azienda Ospedaliero-Universitaria di Bologna

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Pier Luigi Zinzani, MD

CONTACT

+390512143680pierluigi.zinzani@unibo.it

Cinzia Pellegrini, MD

CONTACT

+390512143680cinzia.pellegrini@aosp.bo.it

Study Design

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

Study Record Dates

First Submitted

December 3, 2024

First Posted

February 7, 2025

Study Start

December 7, 2021

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 1, 2026

Last Updated

February 7, 2025

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)