Ignite Creation Date:
2024-05-06 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 1:53 PM
Study NCT ID:
NCT04699344
Status:
UNKNOWN
Last Update Posted:
2021-01-07
First Post:
2021-01-06
Brief Title:
A Prospective Single-centreSingle-blinded Study of PROUD for Prostate Carcinoma Diagnosis
Sponsor:
Qilu Hospital of Shandong University
Organization:
Qilu Hospital of Shandong University
Study Overview
Official Title:
A Prospective Single-centreSingle-blinded Study of PROUD for Prostate Carcinoma Diagnosis
Status:
UNKNOWN
Status Verified Date:
2021-01
Last Known Status:
RECRUITING
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:
None
Brief Summary:
Prostate carcinoma PC is common malignancy and is considered to be the highest incidence in the old males The traditional diagnostic methods of PC present with some shortcomings For example the specificity of serum PSA remains low while prostate needle biopsy is invasive and false negative in some case even causing missed diagnosis of some high risk PC and over diagnosis of PC is not rare Therefore a noninvasive diagnostic method with high accuracy is urgently needed Our previous study has proved that PROstate cancer Urine Detector PROUD which is able to detect chromosomal aberrations of the urine exfoliated cells is a reliable method in diagnosing urothelial carcinoma with sensitivity and specificity of 825 and 969 respectively But its potential in PC diagnosis hasnt been assessed yet and the accuracy of PROUD in detecting PC need to be validated We here intended to investigate whether PROUD can be used in PC diagnosis and further validate the accuracy of PROUD in diagnosing PC
Detailed Description:
The traditional diagnostic methods of PC include serum PSA and prostatic biopsy PB To screen the PC in high risk population PSA is commonly used The early detection of PC is actually carried out by the association of digital rectal examination DRE and serum total prostate-specific antigen tPSA level The usual upper limit for tPSA is 4 ng ml-1 However between 4 and 10 ng ml-1 there exists a diagnostic grey zone with an estimated probability of only 40 of PC in men with normal findings on DRE Prostrate cancer can only be accurately differentiated from benign prostate hyperplasiaBPH and prostatitis by pathological proof usually obtained by subsequent invasive PB To refine the indications for PB and therefore to reduce morbidity new indicators based on tPSA were developed age-adjusted tPSA cutoffs tPSA velocity or tPSA density where the elevated tPSA is indexed to the gland size The most commonly used indicator is freetotal PSA ratio ftPSA which may help to predict PC or BPH in its extreme values However the probability of PC at biopsy among men with a PSA value between 4 and 10 ng ml-1 and normal findings on DRE ranged from 56 for men with an ftPSA ratio of 10 to 8 for men with a ratio 25 underlying the lack of accuracy of the ftPSA indicator PB is the gold standard diagnostic procedure which is invasive uncomfortable and with possible adverse side effects as local bleeding and infectious complications including drug resistant bacterial strains Furthermore repeated tissue biopsy is needed in some cases for the missed diagnosis of PC in the other hand causing over diagnosis of the insignificant clinical PC cases
The difficulty of estimating the risk of PC when there is a suspicious DRE without nodule when tPSA ranges between 4 and 10 ng ml-1 or when ftPSA has an average value between 15 and 25 taken together with the morbidity due to PB highlights the need of new predictive markers for PC
In urine samples it is reported than whole-genome gene expression analysis as noninvasive method obtained from PC BPHand control groups by using the microarray system showed the differences of gene expression profilesTo improve the specificity of prostate cancer diagnosis prostate-cancer-specific markers such as prostate cancer gene 3 PCA3are needed The strong association between PCA3 mRNA overexpression and malignant transformation of prostate epithelium indicates its potential as a diagnostic biomarker The PCA3 test of PC has a sensitivity ranged from 47-69 and specificity from 72-83
Copy number variations CNVs refers to the ongoing acquisition of genomic alterations ranging from point mutations to gross chromosomal rearrangements is a hallmark of cancer which is found in 60-80 of human cancer and it positively correlates with high tumor stage poor prognosis metastasis and therapeutic resistance Several researches have investigated the value of detecting chromosomal instability with sWGS in either cell-free cfDNA or genomic DNA as a noninvasive diagnostic method for cancers and yielded quite fine results Our previous research has also proved the PROUD model reached performance of AUC0928 with sensitivity specificity and accuracy of 825 969 and 890 respectively This test also showed superiority in diagnosing upper tract urothelial carcinoma compared with urinary cytology test
Here we intended to conduct a prospective multicenter single-blinded research to further validate the value of PROUD in diagnosing PC by analyzing the CNV level of patient DNA extracted from urine exfoliated cells
The difficulty of estimating the risk of PC when there is a suspicious DRE without nodule when tPSA ranges between 4 and 10 ng ml-1 or when ftPSA has an average value between 15 and 25 taken together with the morbidity due to PB highlights the need of new predictive markers for PC
In urine samples it is reported than whole-genome gene expression analysis as noninvasive method obtained from PC BPHand control groups by using the microarray system showed the differences of gene expression profilesTo improve the specificity of prostate cancer diagnosis prostate-cancer-specific markers such as prostate cancer gene 3 PCA3are needed The strong association between PCA3 mRNA overexpression and malignant transformation of prostate epithelium indicates its potential as a diagnostic biomarker The PCA3 test of PC has a sensitivity ranged from 47-69 and specificity from 72-83
Copy number variations CNVs refers to the ongoing acquisition of genomic alterations ranging from point mutations to gross chromosomal rearrangements is a hallmark of cancer which is found in 60-80 of human cancer and it positively correlates with high tumor stage poor prognosis metastasis and therapeutic resistance Several researches have investigated the value of detecting chromosomal instability with sWGS in either cell-free cfDNA or genomic DNA as a noninvasive diagnostic method for cancers and yielded quite fine results Our previous research has also proved the PROUD model reached performance of AUC0928 with sensitivity specificity and accuracy of 825 969 and 890 respectively This test also showed superiority in diagnosing upper tract urothelial carcinoma compared with urinary cytology test
Here we intended to conduct a prospective multicenter single-blinded research to further validate the value of PROUD in diagnosing PC by analyzing the CNV level of patient DNA extracted from urine exfoliated cells
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