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LymphomaNCT06714045

Mediastinal Recurrence of Lympho-proliferative Disorders: a Biopsy is Needed

An observational study of Lymphoma, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lymphoma
How many people
153 participants
Where
1 siteItaly
Study dates
12 Sep 2001to 22 Jun 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Adult, Older adult

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

Who may be able to join

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

Who cannot join

  • incomplete or missing data

Trial locations and contacts

1 site in 1 country.

Italy1 site
  • IRCCS Azienda Ospedaliero Universitaria di Bologna

    Bologna, Emilia-Romagna, 40138

Other trials in Italy

About this study

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.

Read the detailed description

18 FDG PET is currently the gold standard for the staging of lymphoproliferative disorders such as lymphoma and a routine investigation for re-evaluation after first-line treatment; it is also a well-established re-evaluation modality in case of suspected disease recurrence.

Although FDG-PET/CT has an average sensitivity of 90% and a specificity of 91%, its diagnostic performance in combination with surgical biopsy has not yet been extensively evaluated.(1,2) The high predictive value of a negative PET scan, in the appropriate clinical context, helps to identify those patients with a complete metabolic response and therefore in complete remission.

In contrast, the persistence of metabolic activity (PET positivity) after systemic treatment cannot categorically confirm (or exclude) the presence (or absence) of viable lymphomatous tissue, due to the potential association of inflammatory reactions, which are normally manifested by increased hypercapture on PET scan.

For this reason, the persistence or reappearance of mediastinal hypermetabolic activity, in asymptomatic patients with no signs or symptoms of relapse, requires biopsy confirmation before making a diagnosis of disease relapse.

Current guidelines do not recommend the use of PET for the follow-up of patients in remission after lymphoma therapy due to its limited positive predictive value and considering the unequivocal correlation between hypermetabolic findings and definite disease relapse. However, an aggressive disease, in a district such as the mediastinum - where the rapid growth of a neoplastic disease may exacerbate symptoms of particular relevance due to the occupation of space or due to the infiltration of vital structures - may require a more thorough radiological follow-up including precisely the use of PET. Obviously, the discovery of a hypermetabolic finding in a completely asymptomatic patient requires histological confirmation of the relapse before making the definitive diagnosis of neoplastic recurrence.

For this reason, in these patients, the use of PET during follow-up helps to identify early metabolically suspicious lesions growing after remission from an aggressive neoplasm and to avoid, with timely therapeutic treatment, the appearance of particularly severe and sometimes extremely risky symptoms for the patient.

The finding of hypermetabolic mediastinal lesions, if the oncohaematologist recommends biopsy sampling, directs the surgeon to the most appropriate site for sampling considering that:

After treatment for lymphoma, coarse mediastinal masses with an inhomogeneous content (viable tissue alternating with necrotic tissue) and diffusely fibrotic often remain In the case of possible persistence of disease after first-line treatment, a voluminous mediastinal mass may be found on CT scan, while the hypermetabolic tissue (the site of suspected active lymphomatous residue) may be limited in size and sometimes focal.

Some lymphomatous diseases, at the time of relapse, may not be immediately identifiable by conventional radiology, particularly on CT scan, but may only be revealed by a functional investigation such as PET scan.

From a strictly surgical point of view, once the need to perform a biopsy has been established, the purely diagnostic nature of the procedure forces one to look for the least invasive access route, which is at low risk of complications and ensures a rapid convalescence.

The case history generated by a more than 20-year collaboration between the Seràgnoli Institute of the University Hospital and the Thoracic Surgery of the Maggiore Hospital in Bologna will be reviewed. The first 30 cases were published in 2007(3). Considering the lack of data in the reference literature, we will present the results of the review of the surgical approaches used in about 180 patients, the largest available case series on the subject.

Conditions
Lymphoma
Medical subject headings
Lymphoma

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 30 days after the surgery

Secondary outcomes (1)
  1. secondary outcomes

    Evaluate the sensitivity and specificity of the surgical techniques used to perform mediastinal biopsy sampling and assess the incidence of complications and hospitalisation times of each type of surgery: needle biopsy, mediastinoscopy, anterior mediastinotomy, cervico-manubriotomy, VATS and other more unusual surgical accesses, normally used in clinical practice for other pathologies as well, chosen from time to time on the basis of scintigraphic and radiological imaging in suspected lymphoma recurrence/persistence.

    Measured: 30 days after the surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Dec 2024
  2. Study start12 Sep 2001
  3. Primary completion22 Jun 2024
  4. Study completion22 Jun 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Ecologic or community
Time perspective
Retrospective
Enrolment
153 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06714045
Sponsor's protocol ID
MRLPD
Status last verified
Oct 2024
First submitted
28 Nov 2024
Last updated
3 Dec 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Lymphoma, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

primary outcomes (time frame: 30 days after the surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2024.

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