NCT06714045

Brief Summary

We would like to emphasise the need to perform a biopsy in patients with suspected persistence/recurrence of disease; the need to carefully plan the access route to minimise the risk of false negatives; the possibility of performing biopsies through all minimally invasive access routes available to the thoracic surgeon ensuring rapid clinical recovery and timely resumption of medical treatment in the event of recurrence.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
153

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2001

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

September 12, 2001

Completed
22.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 22, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 22, 2024

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 28, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 3, 2024

Completed
Last Updated

December 3, 2024

Status Verified

October 1, 2024

Enrollment Period

22.8 years

First QC Date

November 28, 2024

Last Update Submit

November 28, 2024

Conditions

Lymphoma

Outcome Measures

Primary Outcomes (1)

  • primary outcomes

    Verify the need for histological confirmation in patients undergoing cytotoxic therapy for lymphoma presenting radiological/scintigraphic signs of suspected persistence or mediastinal recurrence of disease.

    30 days after the surgery

Secondary Outcomes (1)

  • secondary outcomes

    30 days after the surgery

Eligibility Criteria

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

Patients who underwent needle biopsy or surgical biopsy for suspected persistence or recurrence of lymphoma after cytotoxic treatment at the IRCCS Azienda Ospedaliero-Universitaria di Bologna Thoracic Surgery between 1 January 2002 and 31 January 2023

You may qualify if:

  • Radiographic/scintigraphic suspicion of lymphoma persistence/recurrence after cytotoxic treatment Patients undergoing mediastinal biopsy procedure Obtaining informed consent.

You may not qualify if:

  • incomplete or missing data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Azienda Ospedaliero Universitaria di Bologna

Bologna, Emilia-Romagna, 40138, Italy

Location

MeSH Terms

Conditions

Lymphoma

Condition Hierarchy (Ancestors)

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

Study Officials

  • Sergio Nicola Forti Parri, MD

    IRCCS Azienda Ospedaliero-Universitaria di Bologna

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 28, 2024

First Posted

December 3, 2024

Study Start

September 12, 2001

Primary Completion

June 22, 2024

Study Completion

June 22, 2024

Last Updated

December 3, 2024

Record last verified: 2024-10

Locations

IT(1)