NCT05989555

Brief Summary

Blood will be drawn 1 month before and 2 month after regular radioactive iodine treatment. Monocytes will be isolated. The three main outcomes are whole blood counts, cytokine production upon in vitro stimulation of monocytes and in vitro ROS production by monocytes. These results are compared between patients treated in adjuvant setting and patients treated for persistent structural disease, and between pre- and post-treatment status.

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
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2024

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 4, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 14, 2023

Completed
5 months until next milestone

Study Start

First participant enrolled

January 1, 2024

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

November 18, 2023

Status Verified

November 1, 2023

Enrollment Period

1.4 years

First QC Date

August 4, 2023

Last Update Submit

November 16, 2023

Conditions

Thyroid Carcinoma, Nonmedullary

Keywords

radioactive iodineinnate immune systemmonocytes

Outcome Measures

Primary Outcomes (3)

  • Whole blood counts

    Whole blood counts with leukocyte subtypes (neutrophils, lymphocytes and monocytes) are compared before and after radioactive iodine treatment

    2 months

  • Cytokine production upon monocyte stimulation

    Cytokine produciton (tumor necrosis factor, interleukin-6, interleukin-8) will be compared before and after treatment with radioactive iodine

    2 months

  • Reactive oxygen species (ROS) production by monocytes

    In vitro ROS production by monocytes will be compared before and after treatment with radioactive iodine

    2 months

Secondary Outcomes (2)

  • Monocyte transcriptome

    2 months

  • Plasma proteome

    2 months

Study Arms (2)

I/adjuvant

15 patients with thyroid carcinoma that are treated with radioacitive iodine in an adjuvant setting

Other: Blood drawing

II/structutral disease

15 patients with thyroid carcinoma that are treated with radioactive iodine with the indication of persistent structural disease

Other: Blood drawing

Interventions

Blood drawingOTHER

Blood is drawn twice in all subjects. Once before treatment with radioacitve iodine and once after.

I/adjuvantII/structutral disease

Eligibility Criteria

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

Thirty patients with non-medulary thyroid carcinoma

You may qualify if:

  • Pathologically confirmed non-medullary thyroid cancer
  • Undergoing radioactive iodine treatment in an adjuvant setting or for persistent structural disease
  • Aged ≥ 18 years

You may not qualify if:

  • Inflammatory or infectious comorbidities
  • Using medication interfering with the immune system
  • Pregnancy
  • A self-reported alcohol consumption of \>21 units per week
  • Other active malignancies, defined as malignancies not in complete remission for \<2 years
  • Previous systemic anti-cancer treatment such as chemotherapy, targeted therapy, radiotherapy or immunotherapy within 3 years before study procedures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Radboud University Medical Center

Nijmegen, Netherlands

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Peripheral blood mononuclear cells and monocytes will be isolated from whole blood. The monocytes will be stimulated in vitro. Supernatants will be stored.

MeSH Terms

Conditions

Thyroid Cancer, Papillary

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Adenocarcinoma, PapillaryAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsThyroid NeoplasmsEndocrine Gland NeoplasmsNeoplasms by SiteHead and Neck NeoplasmsEndocrine System DiseasesThyroid Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Central Study Contacts

Pepijn van Houten, M.D.

CONTACT

+31243614599pepijn.vanhouten@radboudumc.nl

Prashant Changoer, Msc.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 4, 2023

First Posted

August 14, 2023

Study Start

January 1, 2024

Primary Completion

June 1, 2025

Study Completion

December 1, 2025

Last Updated

November 18, 2023

Record last verified: 2023-11

Locations

NL(1)