NCT04822974

Brief Summary

Torque Teno Virus (TTV) prevalence in the general population is very high (\>90%) and has not been consistently confirmed to cause any disease. Kidney transplant studies seem to indicate that an elevated viremia could predict the risk of de-veloping an infectious process in the following weeks. An study of the influence of TTV as a predictive marker of infection in kidney transplant recipi-ents showed higher TTV levels, even 3 months before the infectious process, allowing the authors to postulate that the quantification of TTV could help to modulate the treatment of patients at risk. Publications of subsequent studies seem to confirm these data.In the field of hematopoietic stem cell transplantation (HSCT) few studies have analyzed the replication kinetics of TTV. There seems to be a drop in TTV plasma load after conditioning treatment, with a progressive increase in the first months post-transplant, in parallel with the number of lymphocytes. In early stages of HSCT, a relation-ship between TTV replication kinetics and the probability of developing an infection by CMV has also been described. Likewise, the possible relationship of TTV with other complications of HSCT, such as Epstein-Barr virus infection (EBV) or graft-versus-host disease (GvHD), have been reported. However, not every study conducted to date show this line of results.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2021

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

First Submitted

Initial submission to the registry

March 24, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 30, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

March 30, 2021

Status Verified

March 1, 2021

Enrollment Period

1 year

First QC Date

March 24, 2021

Last Update Submit

March 26, 2021

Conditions

Hematologic Cancer

Outcome Measures

Primary Outcomes (1)

  • Plasma viral load and TTV replication kinetics

    comparaition between before during and after CART

    d0, d1, d3, d5, d7, d10, d14, d21, d28, d60 and d90 after CAR-T Cell treatment

Secondary Outcomes (3)

  • Plasma viral load and CMV replication kinetics

    d0, d14, d28, d60 and d90 after CAR-T Cell treatment

  • infections

    100 days

  • Cytokines

    d0, d3, d7, d10 and d14 after CAR-T Cell treatment

Study Arms (1)

STUDY ARM

EXPERIMENTAL

blood samples collection

Other: blood collection

Interventions

blood collectionOTHER

longitudinally collection of blood samples for each patient included.

STUDY ARM

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients (\>=18 years).
  • Patient going to be treated by CAR-T Cell therapy
  • Able to comply with the protocol.
  • Written informed consent.
  • Patient affiliated to the national "Social Security" regimen or beneficiary of this regimen

You may not qualify if:

  • Pregnancy/breast feeding.
  • Patient considered socially or psychologically unable to comply with the treatment and the required medical follow-up.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Benzaquen A, Gimenez E, Iacoboni G, Guerreiro M, Hernani R, Albert E, Carpio C, Balaguer A, Perez A, S de la Asuncion C, Sanchez-Salinas MA, Chorao P, Pinana JL, Beas F, Montoro J, Hernandez-Boluda JC, Facal A, Ferrer B, Villalba M, Amat P, Gomez MD, Campos D, Terol MJ, Sanz J, Barba P, Navarro D, Solano C. Torque Teno Virus plasma DNA load: a novel prognostic biomarker in CAR-T therapy. Bone Marrow Transplant. 2024 Jan;59(1):93-100. doi: 10.1038/s41409-023-02114-0. Epub 2023 Nov 2.

    PMID: 37919456DERIVED

MeSH Terms

Conditions

Hematologic Neoplasms

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Central Study Contacts

DOMINIQUE GENRE, DR

CONTACT

0491223778drci.up@ipc.unicancer.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 24, 2021

First Posted

March 30, 2021

Study Start

May 1, 2021

Primary Completion

May 1, 2022

Study Completion

September 1, 2022

Last Updated

March 30, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share