An interventional study of Collection of human biofluids and Patient reported outcome measures in Prostate Cancer, Prostate Adenocarcinoma and Prostatic Neoplasms, sponsored by University Hospital, Ghent. Completed at 1 site in Belgium. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-12-01.
Sponsored by University Hospital, Ghent · Not applicable, Interventional, and Basic science
Radiotherapy (RT) of the abdomen and/or pelvis is known to cause acute and late gastrointestinal (GI) toxicities. While radiation dose and volume are known risk factors for developing such side effects, recent evidence suggests patterns of disturbance in the composition of the GI microbiota - so called "dysbiosis" - may also promote the host's susceptibility to GI toxicities through impaired intestinal barrier function and inflammation. The IMPRINT-study aims to expand the current knowledge on the role of intestinal bacteria and their metabolites involved in the pathophysiology of radiation-induced GI toxicities by longitudinally examining the microbiota composition (feces), the associated metabolome (blood, feces and urine) and bacterial extracellular vesicles (BEVs) (blood and feces).
The IMPRINT-study is a prospective biomarker study assessing the impact of different treatment field sizes and associated radiation doses on the patient's microbiome and metabolome, whereby the link with radiation-induced GI toxicities will be emphasized. Blood, urine and fecal samples will be longitudinally collected at 4 different time points: (1) shortly before, (2) during and (3) shortly after RT treatment, as well as (4) one-month post-RT. To our knowledge, this is the first clinical research project relating the impact of multiple radiation parameters on fecal-, urine- and blood-based biomarkers to risk of GI toxicities in a homogeneously defined study population.
6,367 studies on the registry are indexed under Prostatic Neoplasms; 1,397 are open to participants now.
This study's enrollment of 50 is below the median of 58 across 4,821 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →University Hospital, Ghent is the lead sponsor of 665 studies on the registry; 156 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Primary, adjuvant or salvage RT of the prostate (bed) without RT of the pelvic nodal regions in the small pelvis, according to local hospital guidelines and protocols.
Other: Collection of human biofluids · Other: Patient reported outcome measures
Primary, adjuvant or salvage RT of the pelvic nodal regions in the small pelvis with possible additional RT of the prostate (bed), according to local hospital guidelines and protocols.
Other: Collection of human biofluids · Other: Patient reported outcome measures
Feces, blood and urine: (1) shortly before, (2) during and (3) shortly after RT treatment, as well as (4) one-month post-RT
EORTC QLQ-C30, PR25: (1) shortly before and (2) shortly after RT treatment, as well as (3) one-month post-RT
Microbiome profiles as assessed by fecal samples
Characterization of dynamic changes in the intestinal microbiota composition using 16S rRNA sequencing technology
Time frame: Up to 3.5 months after inclusion
Metabolome profiles as assessed by fecal, blood and urine samples
Characterization of dynamic changes in the concentration of all small molecules (metabolites) in feces, blood and urine using ultra-high performance liquid chromatography coupled to high-resolution mass spectrometry (UHPLC-HRMS)
Time frame: Up to 3.5 months after inclusion
Discovery of potential predictive biomarkers for the development of RT-induced GI toxicities
The identified microbiota and metabolite signatures will be investigated for association with incidence and severity of GI toxicities
Time frame: Up to 3.5 months after inclusion
Incidence of GI and Genitourinary (GU) toxicities
GI and GU toxicities as per Common Terminology for Adverse Events (CTCAE) v4.0
Time frame: Up to 3.5 months after inclusion
Patient reported QOL as per EORTC-QLQ C30
Validated questionnaire assessing different health-related parameters (psychological, physical and social well-being) in cancer patients
Time frame: Up to 3.5 months after inclusion
Patient reported QOL as per EORTC-QLQ PR25
Validated questionnaire assessing the health-related QOL of prostate cancer patients
Time frame: Up to 3.5 months after inclusion
Concentration of BEVs in fecal and blood samples
BEVs in fecal and blood samples will be separated and analyzed through the orthogonal implementation of ultrafiltration, size-exclusion chromatography (SEC) and density-gradient centrifugation, followed by biochemical characterization
Time frame: Up to 3.5 months after inclusion
This study is completed, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University Hospital, Ghent