Trial · NCT05513469
Biomarker Identification of Radionuclide Therapy-induced Radiation Responses
NCT05513469, Not applicable, Unknown, Erasmus Medical Center
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Biomarker Identification of Radionuclide Therapy-induced Radiation Responses. Trials, record NCT05513469. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05513469
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Biomarker Identification of Radionuclide Therapy-induced Radiation Responses
- NCT number
- NCT05513469
- Status
- Unknown
- Phases
- Not applicable
- Enrollment
- 20 participants, estimated
- Lead sponsor
- Erasmus Medical Center
- Conditions
- Neuroendocrine Tumors
- Interventions
- Lutathera
- First posted
- 2022-08-24
- Last updated
- 2023-04-07
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Transcriptional regulation and DNA damage induction in PBMCs after PRRT. | 2 years | DNA damage will be assessed by immunofluorescent stainings and microscopic detection of γ-H2AX and 53BP1 RIF. RIF numbers of at least 50 cells from at least 4 fields of view per blood sample will be quantified using an automated quantification macro in ImageJ. RNA isolation, sequencing, analysis and qPCR validation will be done. Validation of the identified differentially expressed genes will be performed in triplicate by qPCR. For sequencing, we will use an unique in-house analysis method using a Snakemake pipeline. RIF and sequencing analysis will be performed on blinded samples to perform unbiased analysis. |
| Secondary | mimic transcriptional regulation and DNA damage induction in PRRT ex vivo. | 2 years | Untreated blood from the patient will be treated with 177Lu-DOTATATE ex vivo. Analysis of transcriptional regulation and DNA damage induction will be done as mentioned in the description of outcome 1. |
| Secondary | detection of ctDNA in NET patients | 2 years | For the assessment of circulating biomarkers of the tumor cells we will measure ctDNA levels in the blood. |
| Other | Evaluate the effect of PRRT on ctDNA levels. | 2 years | ctDNA levels will be measured in the blood before PRRT and 8 weeks after the first cycle. |
| Other | methylation sequencing ctDNA | 2 years | DNA methylation sequencing method will be used to analyze the ctDNA. The MeD-seq assay will be used for genome-wide DNA methylation profiling on cell-free DNA (cfDNA) |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05513469
GET https://conductscience.org/api/trials/v1/NCT05513469/registered