Prostatic NeoplasmsNCT02940977
Establishment and Clinical Assessment of a Prostate Cancer (PCa) Risk Model Based on the Updated Circulating Tumor Cell (CTC) Detection Technique
An observational study of Prostatic Neoplasms and Prostatic Adenoma, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
1. To elucidate the role of CTC detection in the evaluation of risk level in PCa patients, and establish a mathematic model for predicting the pathological status. 2. To explore the possible subtle change in CTC condition after radical prostatectomy. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostatic Neoplasms, Prostatic Adenoma
- What is being tested?
- Blood draws
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2016to 30 Mar 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with prostate cancer, confirmed with needle biopsy, and suitable for radical prostatectomy, and have not received any treatments before.
Who may be able to join
- Diagnosed with PCa by biopsy, for the first time.
- Clinical assessed suitable for radical prostatectomy
- Age ≥ 18 years, able to provide written informed consent
- No prior systematic or regional treatment for PCa.
- No neuro-endocrine differentiation or small cell PCa pattern.
- ECOG status 0-1
- Expected life span ≥ 12 months.
- Multiorgan function (heart, lung, liver, kidney) able to tolerate radical prostatectomy, and meet the standard of this study.
Who cannot join
- Severe concomitant disease or infection.
- ALT or AST > 2.5 ULN, or total bilirubin > 1.5 ULN; Creatinine >177umol/L(2.5mg/dL)；Plt < 100,000/uL, Neutrophil <1,500/uL.
- Known or suspected brain metastasis or leptomeningeal carcinomatosis.
- Another malignancy in the last 5 years, excluding completely cured melanoma.
- Severe cardiovascular disease, including:
- Myocardial infarct within 6 months; Uncontrolled angina pectoris within 3 months; Congestive heart failure; Ventricular arrhythmia history with clinical significance; Morbiz type Ⅱ or complete heart block
- Major surgery (general anesthesia) within 4 weeks.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200092
Jun Qi, MD., +86-021-25078080, qijun@xinhuamed.com.cn
Jun Qi, MD.
About this study
- To elucidate the role of CTC detection in the evaluation of risk level in PCa patients, and establish a mathematic model for predicting the pathological status.
- To explore the possible subtle change in CTC condition after radical prostatectomy.
Read the detailed description
- Detect and evaluate the CTC status (a total of 3 times: 1 day before sugery, 3/12 months after surgery) for all of the PCa patients enrolled. Analyze the CTC result with PSA level, needle biopsy and radiological imaging information.
- Analyze the difference in CTC amount/Epithelial-Mesenchymal ratio between patients in different D'Amico risk level(low/intermediate/high).
- Establish a mathematic model based on the CTC results and pathological condition observed in operation (OC, organ confined; EPE, extraprostatic extension; SVI, seminal vesicle invasion; LNI, lymph node invasion), and compare this model with the latest version of Partin table.
- Detect and compare the CTC and PSA level 3/12 months after surgery. Evaluate the radiological condition in 12 months after blood draw.
- Conditions
- Prostatic Neoplasms, Prostatic Adenoma
- Being tested
- Blood draws
- Keywords
- Circulating tumor cell, Epithelial to mesenchymal transition, Prostate specific antigen (PSA), Partin table
- Medical subject headings
- Prostatic Neoplasms, Prostatic Hyperplasia, Neoplastic Cells, Circulating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood drawsOther
Blood draws, from peripheral veins, each time 2 tubes, each 5 ml.
| Study group | Role | What they receive |
|---|---|---|
| Prostate cancer patients | Patients diagnosed with prostate cancer, confirmed with needle biopsy, and suitable for radical prostatectomy, and have not received any treatments before. Receives: Other: Blood draws |
What is being measured
The primary outcome is the main question the study is designed to answer.
Circulating tumor cell (CTC) total number and epithelial-intermediate-mesenchymal ratio detected by CTC enrichment and FISH technique
This step should be completed within the day when the peripheral venous blood is drawn.
Measured: 1 day before operation
Pathological findings (whether the patient has: 1.OC, organ confined; 2.EPE, extraprostatic extension; 3. SVI, seminal vesicle invasion; 4. LNI, lymph node invasion) during the radical prostectomy, confirmed by pathology section result
The pathology section evaluation will be done by two pathologists independently. A third pathology expert will join to make a final decision if opposite results are given by the two pathologists.
Measured: On the day of operation
CTC total number and epithelial-intermediate-mesenchymal ratio detected by CTC enrichment and FISH technique
This step should be completed within the day when the peripheral venous blood is drawn.
Measured: 3 months after operation
CTC total number and epithelial-intermediate-mesenchymal ratio detected by CTC enrichment and FISH technique
This step should be completed within the day when the peripheral venous blood is drawn.
Measured: 12 months after operation
Secondary outcomes (4)
Prostate specific antigen (PSA) level measurement using peripheral venous blood
The blood should be drawn together with that for CTC detection
Measured: 3 months after operation
Prostate specific antigen (PSA) level measurement using peripheral venous blood
The blood should be drawn together with that for CTC detection
Measured: 6 months after operation
PSA level measurement using peripheral venous blood
The blood should be drawn together with that for CTC detection
Measured: 9 months after operation
Radiological evaluation including isotope bone scanning and pelvic magnetic resonance imaging (MRI) scan
Radiological evaluation should be conducted after the blood is drawn for CTC and PSA detection.
Measured: 12 months after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2016 (estimated)
- Study start1 Oct 2016
- Primary completion30 Mar 2019 (estimated)
- Study completion30 Mar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic NeoplasmsStudies of the same condition, open and under way.
- More trials run by Xinhua Hospital, Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Shen Kang Hospital Development Center
- Responsible party
- Principal investigator, Jun Qi, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02940977
- Sponsor's protocol ID
- XH-16-028
- Status last verified
- Jul 2018
- First submitted
- 18 Oct 2016
- Last updated
- 10 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishment and Clinical Assessment of a Prostate Cancer (PCa) Risk Model Based on the Updated Circulating Tumor Cell (CTC) Detection Technique
- ClinicalTrials.gov ID
- NCT02940977
- Acronym / sponsor ID
- XH-16-028
- Conditions
- Prostatic Neoplasms, Prostatic Adenoma
- Keywords
- Circulating tumor cell, Epithelial to mesenchymal transition, Prostate specific antigen (PSA), Partin table
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Collaborators
- Shanghai Shen Kang Hospital Development Center
- Study start
- 1 Oct 2016 (actual)
- Primary completion
- 30 Mar 2019 (estimated)
- Study completion
- 30 Mar 2019 (estimated)
- First posted
- 21 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- To elucidate the role of CTC detection in the evaluation of risk level in PCa patients, and establish a mathematic model for predicting the pathological status.
- To explore the possible subtle change in CTC condition after radical prostatectomy.
Detailed description
- Detect and evaluate the CTC status (a total of 3 times: 1 day before sugery, 3/12 months after surgery) for all of the PCa patients enrolled. Analyze the CTC result with PSA level, needle biopsy and radiological imaging information.
- Analyze the difference in CTC amount/Epithelial-Mesenchymal ratio between patients in different D'Amico risk level(low/intermediate/high).
- Establish a mathematic model based on the CTC results and pathological condition observed in operation (OC, organ confined; EPE, extraprostatic extension; SVI, seminal vesicle invasion; LNI, lymph node invasion), and compare this model with the latest version of Partin table.
- Detect and compare the CTC and PSA level 3/12 months after surgery. Evaluate the radiological condition in 12 months after blood draw.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prostate cancer patients | – | Other: Blood drawsPatients diagnosed with prostate cancer, confirmed with needle biopsy, and suitable for radical prostatectomy, and have not received any treatments before. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with prostate cancer, confirmed with needle biopsy, and suitable for radical prostatectomy, and have not received any treatments before.
Key inclusion criteria (8 listed)
- Diagnosed with PCa by biopsy, for the first time.
- Clinical assessed suitable for radical prostatectomy
- Age ≥ 18 years, able to provide written informed consent
- No prior systematic or regional treatment for PCa.
- No neuro-endocrine differentiation or small cell PCa pattern.
Key exclusion criteria (7 listed)
- Severe concomitant disease or infection.
- ALT or AST > 2.5 ULN, or total bilirubin > 1.5 ULN; Creatinine >177umol/L(2.5mg/dL)；Plt < 100,000/uL, Neutrophil <1,500/uL.
- Known or suspected brain metastasis or leptomeningeal carcinomatosis.
- Another malignancy in the last 5 years, excluding completely cured melanoma.
- Severe cardiovascular disease, including:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood drawsBlood draws, from peripheral veins, each time 2 tubes, each 5 ml. | Other | Prostate cancer patients |
Primary outcome
Circulating tumor cell (CTC) total number and epithelial-intermediate-mesenchymal ratio detected by CTC enrichment and FISH technique
Time frame: 1 day before operation
This step should be completed within the day when the peripheral venous blood is drawn.
Pathological findings (whether the patient has: 1.OC, organ confined; 2.EPE, extraprostatic extension; 3. SVI, seminal vesicle invasion; 4. LNI, lymph node invasion) during the radical prostectomy, confirmed by pathology section result
Time frame: On the day of operation
The pathology section evaluation will be done by two pathologists independently. A third pathology expert will join to make a final decision if opposite results are given by the two pathologists.
CTC total number and epithelial-intermediate-mesenchymal ratio detected by CTC enrichment and FISH technique
Time frame: 3 months after operation
This step should be completed within the day when the peripheral venous blood is drawn.
CTC total number and epithelial-intermediate-mesenchymal ratio detected by CTC enrichment and FISH technique
Time frame: 12 months after operation
This step should be completed within the day when the peripheral venous blood is drawn.
4 secondary outcomes
Prostate specific antigen (PSA) level measurement using peripheral venous blood
Time frame: 3 months after operation
Prostate specific antigen (PSA) level measurement using peripheral venous blood
Time frame: 6 months after operation
PSA level measurement using peripheral venous blood
Time frame: 9 months after operation
Radiological evaluation including isotope bone scanning and pelvic magnetic resonance imaging (MRI) scan
Time frame: 12 months after operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2018.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostatic Neoplasms and Prostatic Adenoma, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jun Qi, MD. (021-20578080, jasonqi@sh163.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Circulating tumor cell (CTC) total number and epithelial-intermediate-mesenchymal ratio detected by CTC enrichment and FISH technique (time frame: 1 day before operation). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2018.