NCT05254821

Brief Summary

Molecular analysis identifies residual disease by overcoming the sensitivity of imaging methods and therefore has the potential for integrating with therapy provided by FDG-PET alone. It is a well known fact that tumor DNA circulating in plasma (ctDNA) reflects the mutational profile of tumor cells and can be used to non-invasively detect specific mutations of Hodgkin's lymphoma without the need for microdissecting the histological sample.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
130

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

January 10, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 15, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 24, 2022

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 3, 2024

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 3, 2026

Completed
Last Updated

November 14, 2022

Status Verified

November 1, 2022

Enrollment Period

2.1 years

First QC Date

February 15, 2022

Last Update Submit

November 9, 2022

Conditions

Hodgkin Lymphoma

Keywords

ctDNANext generation sequencingHodgkin lymphoma

Outcome Measures

Primary Outcomes (1)

  • Sensitivity of interim ctDNA genotyping

    Sensitivity of interim ctDNA genotyping in identifying chemorefractory patients or patients with good prognosis (patients who do not progress after 24 months)

    24 months

Eligibility Criteria

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

Male or female adults 18 years or older with a documented diagnosis of hodgkin lymphoma according to WHO 2016 classification

You may qualify if:

  • Male or female adults 18 years or older
  • Documented diagnosis of Hodgkin lymphoma (both classic and nodular predominant lymphocytes subtype) according to 2016 WHO classification
  • Willing and able to comply with scheduled study procedures
  • Evidence of a signed informed consent
  • ECOG performance status 0-2 (or 3, if disease related)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federico II University

Naples, 80130, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

frozen plasma

MeSH Terms

Conditions

Hodgkin Disease

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Claudia Giordano, MD

CONTACT

0817464289claudiagiordano91@hotmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 15, 2022

First Posted

February 24, 2022

Study Start

January 10, 2022

Primary Completion

February 3, 2024

Study Completion

February 3, 2026

Last Updated

November 14, 2022

Record last verified: 2022-11

Locations

IT(1)