Trial Title:
Prognostic Significance of ctDNA in HL
NCT ID:
NCT06263530
Condition:
Prognostic Cancer Model
Conditions: Keywords:
Hodgkin lymphoma
circulating tumor DNA
next generation sequencing
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Summary:
Specific somatic mutations using ctDNA will be analyzed in predefined subgroups of cHL
(e.g., age <60 and ≥ 60 years, EBV). These mutations will be correlated with response to
the treatment in the first line, in the relapse, during brentuximab vedotin and/or
nivolumab treatment. Circulating tumor DNA will be correlated with the extent of tumor
mass and chemo/radiotherapy.
Detailed description:
Samples of plasma from peripheral blood will be taken for investigational ctDNA
examination during the specific timepoints: at diagnosis, after 2 cycles of initial
chemotherapy, at the end of chemotherapy, 3 months after radiotherapy, at the diagnosis
of the first relapse, after salvage chemotherapy before ASCT, 3 months after ASCT, at the
diagnosis of second relapse and every 3 months during brentuximab vedotin treatment or
during nivolumab treatment until progression. The buccal swab for germline DNA extraction
will be performed at the time of enrollment into the study. Samples of peripheral blood
for EBV-DNA analysis will be obtained from the EBV-positive cHL patients to measure EBV
load at the same time-points as ctDNA. Microdissected HRS cells from fresh frozen
biopsies at the diagnosis and at the relapse will be used for tumor cells next generation
sequencing.
Criteria for eligibility:
Study pop:
Patients ≥ 18 years with new HL, all patients will undergo standard diagnostic procedures
and will be divided based by stages and risk factors. Patients below 60 years will be
divided into 3 treatment risk groups and treated according to the standard
recommendations explained as well as elderly patients (see study groups). Younger
relapsed patients will be treated with salvage platinum-based chemotherapy followed by
high-dose chemotherapy and autologous stem cell transplantation (ASCT). Relapses after
ASCT in younger patients or after at least two lines of chemotherapy in elderly patients
will be treated with brentuximab vedotin (up to 16 cycles) or nivolumab until
progression.
Sampling method:
Probability Sample
Criteria:
Inclusion Criteria:
- Patients ≥ 18 years with newly histologically confirmed classical Hodgkin lymphoma
(cHL) will be enrolled
- signing the informed consent
Exclusion Criteria:
- Pacients without signing the informed consent
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Locations:
Facility:
Name:
University Hospital Hradec Kralove
Address:
City:
Hradec Kralove
Zip:
50005
Country:
Czechia
Status:
Recruiting
Contact:
Last name:
Alice Sykorova, M.D., Ph.D.
Phone:
+420495 832 866
Email:
alice.sykorova@fnhk.cz
Facility:
Name:
University Hospital Olomouc
Address:
City:
Olomouc
Zip:
77520
Country:
Czechia
Status:
Recruiting
Contact:
Last name:
Vit Prochazka, prof. M.D.
Phone:
+420588 442 878
Email:
prochazv@fnol.cz
Facility:
Name:
University Hospital Kralovske Vinohrady
Address:
City:
Praha
Zip:
10034
Country:
Czechia
Status:
Recruiting
Contact:
Last name:
Heidi Mocikova, M.D., Ph.D.
Phone:
+420267163554
Email:
heidi.mocikova@fnkv.cz
Contact backup:
Last name:
Katerina Klaskova, Ing.
Phone:
+420267162880
Email:
katerina.klaskova@fnkv.cz
Facility:
Name:
Charles University
Address:
City:
Praha
Zip:
12108
Country:
Czechia
Status:
Active, not recruiting
Facility:
Name:
General University Hospital
Address:
City:
Praha
Zip:
12808
Country:
Czechia
Status:
Recruiting
Contact:
Last name:
Jan Koren, M.D.
Phone:
+420224962541
Email:
jan.koren@vfn.cz
Start date:
January 2, 2022
Completion date:
December 31, 2027
Lead sponsor:
Agency:
Interni hematologicka klinika FNKV
Agency class:
Other
Collaborator:
Agency:
Charles University, Czech Republic
Agency class:
Other
Collaborator:
Agency:
General University Hospital, Prague
Agency class:
Other
Collaborator:
Agency:
University Hospital Olomouc
Agency class:
Other
Collaborator:
Agency:
University Hospital Hradec Kralove
Agency class:
Other
Collaborator:
Agency:
University Hospital, Motol
Agency class:
Other
Source:
Interni hematologicka klinika FNKV
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06263530
