Ignite Creation Date:
2024-05-06 @ 5:15 PM
Last Modification Date:
2024-10-26 @ 2:25 PM
Study NCT ID:
NCT05246774
Status:
RECRUITING
Last Update Posted:
2023-04-28
First Post:
2022-02-09
Brief Title:
Study of Serum and Urinary Biomarkers and Radiation Cystitis in Patients Treated With Radiotherapy for Localized Prostate Cancer
Sponsor:
Direction Centrale du Service de Santé des Armées
Organization:
Direction Centrale du Service de Santé des Armées
Study Overview
Official Title:
Study of Serum and Urinary Biomarkers and Radiation Cystitis in Patients Treated With Radiotherapy for Localized Prostate Cancer
Status:
RECRUITING
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RABBIO
Brief Summary:
Prostate cancer represents the 1st diagnosed cancer in men with 50400 new cases and 8100 deaths in 2018 Improved diagnostic and therapeutic strategies have led to a 37 decrease in mortality between 2010 and 2018 with a 5- and 10-year survival rate of 93 and 80 respectively
Pelvic conformal radiotherapy is an important therapeutic technique in the management of pelvic cancers particularly prostate cancer However despite the improvement in radiation techniques this technique is responsible for acute and late adverse events at the bladder level these symptoms being grouped under the term radiation cystitis It has a clear impact on the quality of life of patients Acute radiation cystitis is likely to occur during treatment or within 3 months after radiotherapy Its incidence is estimated at nearly 50 The late form appears on average 2 years after radiation but can sometimes occur 10 or 20 years later Its incidence is 5 to 10 of cases
Although certain factors have been identified such as the dose received fractionation or comorbidities the pathophysiology of radiation-induced cystitis remains unclear particularly because of the risks of complications arising from access to bladder tissue post-irradiation thus limiting our knowledge as well as the therapies targeting this process The use of biomarkers in liquid biopsies allows us to understand the problem of access to irradiated tissues and to highlight protein changes prognostic of radiation-induced visceral toxicity
Few works are published on the evaluation of inflammatory and pro-fibrotic biomarkers of radiation-induced cystitis in liquid biopsies Only 2 retrospective studies have shown a correlation between late radiation cystitis and increased levels of plasminogen activator inhibitor 1 PAI-1 matrix metalloproteinase inhibitors TIMP1 and TIMP2 hepatocyte growth factor HGF vascular endothelial growth factor VEGF and placental growth factor PIGF in urine However none of these studies explored the variation of biomarkers in the early stage of radiation-induced bladder toxicity
This would suggest the feasibility of prospective assay of overexpression of these proteins in liquid biopsies
Pelvic conformal radiotherapy is an important therapeutic technique in the management of pelvic cancers particularly prostate cancer However despite the improvement in radiation techniques this technique is responsible for acute and late adverse events at the bladder level these symptoms being grouped under the term radiation cystitis It has a clear impact on the quality of life of patients Acute radiation cystitis is likely to occur during treatment or within 3 months after radiotherapy Its incidence is estimated at nearly 50 The late form appears on average 2 years after radiation but can sometimes occur 10 or 20 years later Its incidence is 5 to 10 of cases
Although certain factors have been identified such as the dose received fractionation or comorbidities the pathophysiology of radiation-induced cystitis remains unclear particularly because of the risks of complications arising from access to bladder tissue post-irradiation thus limiting our knowledge as well as the therapies targeting this process The use of biomarkers in liquid biopsies allows us to understand the problem of access to irradiated tissues and to highlight protein changes prognostic of radiation-induced visceral toxicity
Few works are published on the evaluation of inflammatory and pro-fibrotic biomarkers of radiation-induced cystitis in liquid biopsies Only 2 retrospective studies have shown a correlation between late radiation cystitis and increased levels of plasminogen activator inhibitor 1 PAI-1 matrix metalloproteinase inhibitors TIMP1 and TIMP2 hepatocyte growth factor HGF vascular endothelial growth factor VEGF and placental growth factor PIGF in urine However none of these studies explored the variation of biomarkers in the early stage of radiation-induced bladder toxicity
This would suggest the feasibility of prospective assay of overexpression of these proteins in liquid biopsies
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2021-A03196-35 | OTHER | IDRCB | None |