- |||||||||| Rencarex (girentuximab) / Heidelberg Pharma, Esteve, Merck (MSD)
Enrollment change: Safety Study With the Antibody, cG250, and Isotope, 124-Iodine, to Diagnose Patients With Renal Masses. (clinicaltrials.gov) - May 14, 2021
P1, N=26, Completed,
FU imaging with In-girentuximab-SPECT is feasible after ccRCC cryoablation and may contribute to early detection of residual or recurrent disease. N=54 --> 26
- |||||||||| Rencarex (girentuximab) / Heidelberg Pharma, Esteve, Prometheus
Clinical, Journal: DNA Methylation in LIME1 and SPTBN2 Genes Is Associated with Attention Deficit in Children. (Pubmed Central) - Feb 13, 2021
Five candidate CpG sites (cg00446123, cg20513976, cg07922513, cg17096979, and cg02506324) in four genes (LIME1, KCNAB2, CAPN9, and SPTBN2) were further examined with pyrosequencing...Therefore, DNA methylation of two CpG sites in LIME1 and one CpG site in SPTBN2 is associated with attention deficits in children. DNA methylation biomarkers may assist in identifying attention deficits of children in clinical settings.
- |||||||||| clopidogrel / Generic mfg.
Journal: Clopidogrel Resistance Is Associated With DNA Methylation of Genes From Whole Blood of Humans. (Pubmed Central) - Feb 2, 2021
Additionally, differentially methylated sites are partially related to genes and pathways that play key roles in process of circadian entrainment, insulin secretion, and so on. Hence, the mechanism and biological regulation of CR might be reflected through these epigenetic alterations, but future research will need to address the causal relationships.
- |||||||||| Rencarex (girentuximab) / Heidelberg Pharma, Esteve, Prometheus
Preclinical, Journal: CAIX-targeting radiotracers for hypoxia imaging in head and neck cancer models. (Pubmed Central) - Nov 12, 2020
We showed that different CAIX-targeting radiotracers can discriminate a low CAIX-expressing tumor from a high CAIX-expressing head and neck cancer xenografts model. In these hypoxic head and neck xenograft models [In]In-DTPA-girentuximab showed the most promising results.
- |||||||||| Trial completion date, Trial primary completion date: 89Zr-TLX250 for PET/CT Imaging of ccRCC- ZIRCON Study (clinicaltrials.gov) - Oct 19, 2020
P3, N=252, Recruiting,
In these hypoxic head and neck xenograft models [In]In-DTPA-girentuximab showed the most promising results. Trial completion date: Jun 2021 --> Oct 2021 | Trial primary completion date: Dec 2020 --> May 2021
- |||||||||| Rencarex (girentuximab) / Heidelberg Pharma, Esteve, Merck (MSD)
Trial completion date, Trial primary completion date, Metastases: Evaluate The Utility Of 124I-cG250 for The Early Detection Of Response to Therapy In Patients With Metastatic Renal Cell Carcinoma (clinicaltrials.gov) - May 4, 2020
P=N/A, N=17, Active, not recruiting,
The addition of [Zr]Zr-DFO-girentuximab-PET/CT and [F]FDG-PET/CT to CT increases lesion detection compared to CT alone in newly diagnosed good and intermediate prognosis mccRCC patients eligible for watchful waiting. Trial completion date: Apr 2020 --> Apr 2021 | Trial primary completion date: Apr 2020 --> Apr 2021
- |||||||||| Rencarex (girentuximab) / Heidelberg Pharma, Nestle, Esteve
Journal: Girentuximab bringt keinen klinischen Benefit. (Pubmed Central) - Nov 11, 2019
These results indicate that [In]In-DTPA-girentuximab-F(ab') is a promising tracer to image hypoxia-related CAIX expression. No abstract available
- |||||||||| Rencarex (girentuximab) / Heidelberg Pharma, Nestle, Esteve
Biomarker, Clinical, Journal: Epigenome-Wide Association Analysis of Differentially Methylated Signals in Blood Samples of Patients with Non-Small-Cell Lung Cancer. (Pubmed Central) - Aug 29, 2019
This analysis showed two significant differentially methylated changes (cg12169243 [DPH6] and cg25429010 [IMP3]) associated with NSCLC in current smokers, six changes (cg09245319, cg17183999 [USP7], cg06366994 [CPE], cg24992236 [MEG9], cg22144719, and cg22448179 [epidermal growth factor receptor]) associated with epidermal growth factor receptor mutation in patients with adenocarcinoma, and four changes (cg25021476 [RSL24D1], cg04989085 [FAM113B], cg20905681 [CKAP4], and cg26379694) associated with advanced-stage NSCLC compared with stage I NSCLC. The validation of these DNA methylation changes and further research on the related genes may help develop easily accessible biomarkers for the early diagnosis or prognosis of NSCLC.
- |||||||||| Rencarex (girentuximab) / Heidelberg Pharma, Nestle, Esteve
Clinical, Journal: Whole-genome methylation profiling of the retinal pigment epithelium of individuals with age-related macular degeneration reveals differential methylation of the SKI, GTF2H4, and TNXB genes. (Pubmed Central) - Aug 23, 2019
We report the largest genome-wide methylation analysis of RPE in AMD along with associated gene expression changes to date, for the first-time reaching genome-wide significance, and identified novel targets for functional and future therapeutic intervention studies. The novel differentially methylated genes SKI and GTF2H4 have not been previously associated with AMD, and regulate disease pathways implicated in AMD, including TGF beta signaling (SKI) and transcription-dependent DNA repair mechanisms (GTF2H4).
- |||||||||| Rencarex (girentuximab) / Heidelberg Pharma, Esteve, Prometheus
Retrospective data, Journal: Meta-analysis of epigenome-wide association studies of cognitive abilities. (Pubmed Central) - Aug 3, 2019
Across the seven measures of cognitive functioning (meta-analysis n range: 2557-6809), there were epigenome-wide significant (P < 1.7 × 10) associations for global cognitive function (cg21450381, P = 1.6 × 10), and phonemic verbal fluency (cg12507869, P = 2.5 × 10)...We demonstrate a link between blood-based DNA methylation and measures of phonemic verbal fluency and global cognitive ability. Further research is warranted to understand the mechanisms linking genomic regulatory changes with cognitive function to health and disease.
- |||||||||| Rencarex (girentuximab) / Heidelberg Pharma, Esteve, Merck (MSD)
Trial completion date, Trial primary completion date, Metastases: Evaluate The Utility Of 124I-cG250 for The Early Detection Of Response to Therapy In Patients With Metastatic Renal Cell Carcinoma (clinicaltrials.gov) - Jun 12, 2019
P=N/A, N=17, Active, not recruiting,
Nevertheless, patients in the "high risk of recurrence" category after surgery for their disease would benefit from a discussion about the potential benefits of adjuvant treatment and enrolment in ongoing adjuvant trials. Trial completion date: Apr 2019 --> Apr 2020 | Trial primary completion date: Apr 2019 --> Apr 2020
- |||||||||| Enrollment open: 89Zr-TLX250 for PET/CT Imaging of ccRCC- ZIRCON Study (clinicaltrials.gov) - Apr 10, 2019
P3, N=252, Recruiting,
Positron emission tomography/computed tomography imaging with Zr-girentuximab can be a valuable diagnostic tool to identify clear cell renal cell carcinoma. Not yet recruiting --> Recruiting
- |||||||||| Rencarex (girentuximab) / Heidelberg Pharma, Nestle, Esteve
Journal: The role of molecular imaging in the characterization of renal masses. (Pubmed Central) - Apr 7, 2019
Molecular imaging offers a noninvasive means of determining the histology of renal tumors thereby aiding in the risk stratification of patients presenting with a renal mass. Future work aims to develop a molecular imaging test that employs dual radiotracers allowing for the more precise characterization of renal tumors in a convenient single radiologic study.
- |||||||||| Trial completion: 89Zr-girentuximab ) Dosimetry in CCRC Study - ZIR-DOSE (clinicaltrials.gov) - Apr 1, 2019
P1, N=10, Completed,
Future work aims to develop a molecular imaging test that employs dual radiotracers allowing for the more precise characterization of renal tumors in a convenient single radiologic study. Recruiting --> Completed
- |||||||||| Trial completion, Trial completion date, Trial primary completion date: Follow up After Cryoablation of Small Renal Masses. (clinicaltrials.gov) - Jan 11, 2019
P=N/A, N=9, Completed,
Recruiting --> Completed Recruiting --> Completed | Trial completion date: Dec 2018 --> Sep 2018 | Trial primary completion date: Dec 2018 --> Sep 2018
- |||||||||| Enrollment closed, Enrollment change, Trial completion date, Trial primary completion date: Intraoperative Dual-modality Imaging in Renal Cell Carcinoma (clinicaltrials.gov) - Sep 4, 2018
P1, N=30, Active, not recruiting,
Recruiting --> Completed Recruiting --> Active, not recruiting | N=22 --> 30 | Trial completion date: Aug 2018 --> Jun 2019 | Trial primary completion date: Jul 2018 --> Apr 2019
- |||||||||| Rencarex (girentuximab) / Heidelberg Pharma, Esteve, Merck (MSD)
Enrollment closed, Trial completion date, Trial primary completion date, Metastases: Evaluate The Utility Of 124I-cG250 for The Early Detection Of Response to Therapy In Patients With Metastatic Renal Cell Carcinoma (clinicaltrials.gov) - Jun 1, 2018
P=N/A, N=17, Active, not recruiting,
Recruiting --> Active, not recruiting | N=22 --> 30 | Trial completion date: Aug 2018 --> Jun 2019 | Trial primary completion date: Jul 2018 --> Apr 2019 Recruiting --> Active, not recruiting | Trial completion date: Apr 2018 --> Apr 2019 | Trial primary completion date: Apr 2018 --> Apr 2019
- |||||||||| Trial completion date, Trial primary completion date: Follow up After Cryoablation of Small Renal Masses. (clinicaltrials.gov) - Feb 5, 2018
P=N/A, N=12, Recruiting,
Recruiting --> Active, not recruiting | Trial completion date: Apr 2018 --> Apr 2019 | Trial primary completion date: Apr 2018 --> Apr 2019 Trial primary completion date: Dec 2017 --> Dec 2018 | Trial completion date: Dec 2017 --> Dec 2018
- |||||||||| Rencarex (girentuximab) / Heidelberg Pharma, Esteve, Prometheus
Clinical, Journal: Body Mass Index and Survival in a Prospective Randomized Trial of Localized High Risk Renal Cell Carcinoma. (Pubmed Central) - Jan 22, 2018
We reviewed the clinicopathologic records of 845 patients across 14 countries who were enrolled in a prospective, placebo-controlled study of adjuvant girentuximab treatment for high-risk renal cell carcinoma...CONCLUSIONS In a prospective cohort of nephrectomized patients with high-risk disease, obesity is associated with lower risk of lymphatic spread and improved overall survival. IMPACT This is the first study utilizing data from a prospective randomized trial reporting an association between obesity and improved overall survival for patients with clear cell renal cell carcinoma.
- |||||||||| Rencarex (girentuximab) / Heidelberg Pharma, Esteve, Merck (MSD)
Enrollment change, Trial initiation date, Trial withdrawal, Trial primary completion date: REDECT 2: REnal Masses: Pivotal Trial to DEteCT Clear Cell Renal Cell Carcinoma With PET/CT (clinicaltrials.gov) - Dec 22, 2017
P3, N=0, Withdrawn,
IMPACT This is the first study utilizing data from a prospective randomized trial reporting an association between obesity and improved overall survival for patients with clear cell renal cell carcinoma. N=350 --> 0 | Initiation date: Jun 2017 --> Dec 2017 | Not yet recruiting --> Withdrawn | Trial primary completion date: Jul 2018 --> Dec 2018
- |||||||||| Rencarex (girentuximab) / Heidelberg Pharma, Esteve, Prometheus
Trial completion, Trial primary completion date: Zirconium-89-girentuximab PET/CT Imaging in Renal Cell Carcinoma (clinicaltrials.gov) - Jun 19, 2017
P2/3, N=30, Completed,
N=25 --> 20 Recruiting --> Completed | Trial primary completion date: Dec 2017 --> Jun 2017
- |||||||||| Trial primary completion date: Follow up After Cryoablation of Small Renal Masses. (clinicaltrials.gov) - Nov 11, 2015
P=N/A, N=12, Recruiting,
Initiation date: Jun 2015 --> Jun 2017 | Trial primary completion date: Jul 2016 --> Jul 2018 Trial primary completion date: Jun 2016 --> Dec 2017
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