Prostatic NeoplasmsNCT03479359
Learning Curve of Digital Rectal Examination for Prostate Cancer Among Internship
An observational study of Prostatic Neoplasms and Digital Rectal Examination, run by Changhai Hospital at 1 site in China.
Trial summary
The investigators conduct this prospective study to investigate the learning curve of digital rectal examination (DRE) for prostate cancer among internship. The investigators want to know how many DRE are usually needed for internship to be performed in urological practice to obtain a stable DRE accuracy. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostatic Neoplasms, Digital Rectal Examination, Benign Prostatic Hyperplasia
- What is being tested?
- Routine review of DRE results by attending doctors
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 700 participants
- Where
- 1 siteChina
- Study dates
- 26 Feb 2018to 26 Feb 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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Study population: All included internship are graduated from the Second Military Medical University and have already get the M.D. degree
Who may be able to join
- Internship just graduate from the medical school, and agree to attend the study.
- Internship have less than 5 DREs of prostate cancer.
- Patients of any age who are included for prostate biopsy are eligible, the indications for prostate biopsy are as follows: PSA>4ng/ml, fPSA/tPSA<0.16, with suspected palpable nodes in the prostate by DRE of attending doctor, suspected mass in prostate detected by ultrasound examination, magnetic resonance imaging, or computed tomography.
Who cannot join
- Internship who are not willing to attend the study.
- Internship stop doing DRE for continuously 3 months after entering the study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Changhai Hospital
Shanghai, Shanghai Municipality, 200433
Chuanliang Xu, M.D., Ph.D, +86 18930568759, drxuchuanliang@126.com
Yinghao Sun, M.D., Ph.D, sunyhsmmu@126.com
About this study
The investigators conduct this prospective study to investigate the learning curve of digital rectal examination (DRE) for prostate cancer among internship. The investigators want to know how many DRE are usually needed for internship to be performed in urological practice to obtain a stable DRE accuracy.
Read the detailed description
Digital rectal examination (DRE) is a basic physical examination in routine practice in Urology. The DRE is a very important daily practice for screen prostate cancer, and each internship in Urology is required to perform this for patients suspected of prostate cancer or benign prostate hyperplasia. However, how many DRE are usually needed for a internship to perform so as to obtain a stable accuracy in daily practice is currently unknown. The investigators thus conduct this prospective trial to investigate the learning curve of DRE among internship.
- Being tested
- Routine review of DRE results by attending doctors
- Keywords
- Prostate cancer; Benign Prostatic Hyperplasia; Digital Rectal Examination; Accuracy
- Medical subject headings
- Prostatic Neoplasms, Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine review of DRE results by attending doctorsBehavioural
Let the internship regularly compare DRE result and the pathology outcome of prostate biopsy of each patient.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | In this group, internship are given the pathology outcome of each prostate biopsy regularly twice a month. Receives: Behavioral: Routine review of DRE results by attending doctors | |
| Group 2 | In this group, internship are not given the pathology outcome of each prostate biopsy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity of DRE performed by internship will be confirmed by prostate biopsy
To examine the sensitivity and specificity of the DRE performed by internship to reference standard of prostate biopsy in a prospective longitudinal cohort of around 700 participants who will undergo prostate biopsy due to suspect of prostate cancer. The investigators will investigate the sensitivity and specificity of DRE by different internship monthly.
Measured: One year
Secondary outcomes (2)
Sensitivity and specificity of DRE performed by internship with different training plan will be confirmed by prostate biopsy
To examine the sensitivity and specificity of the DRE performed by internship (group 1 with routinely review of pathologic outcome of prostate biopsy twice a month, and group 2 internship who are not told the results of prostate biopsy) to standard reference of prostate biopsy.
Measured: One year
Sensitivity and specificity of DRE performed by internship will be compared to the results of fPSA/tPSA and MRI.
To compare the sensitivity and specificity of DRE to fPSA/tPSA and MRI (not any patients are required to have MRI examination of prostate, this will be determined at the discretion of attending doctor) to reference standard of prostate biopsy.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2018
- Study start26 Feb 2018
- Primary completion26 Feb 2019 (estimated)
- Study completion26 Feb 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Prostatic NeoplasmsStudies of the same condition, open and under way.
- More trials run by Changhai HospitalThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeng Shuxiong, Changhai Hospital
- Investigators
- Chuanliang Xu, M.D., Ph.D, Principal investigator, Second Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03479359
- Sponsor's protocol ID
- CH-Urology-DRE-001
- Status last verified
- Mar 2018
- First submitted
- 8 Mar 2018
- Last updated
- 27 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD will be shared after the results of the study has been published. Related information will be given if request by email is agreed by the principle investigator.
Publications
Halpern JA, Oromendia C, Shoag JE, Mittal S, Cosiano MF, Ballman KV, Vickers AJ, Hu JC. Use of Digital Rectal Examination as an Adjunct to Prostate Specific Antigen in the Detection of Clinically Significant Prostate Cancer. J Urol. 2018 Apr;199(4):947-953. doi: 10.1016/j.juro.2017.10.021. Epub 2017 Oct 20.
PubMed 29061540Clements MB, Schmidt KM, Canfield SE, Gilbert SM, Khandelwal SR, Koontz BF, Lallas CD, Liauw S, Nguyen PL, Showalter TN, Trabulsi EJ, Cathro HP, Schenkman NS, Krupski TL. Creation of a Novel Digital Rectal Examination Evaluation Instrument to Teach and Assess Prostate Examination Proficiency. J Surg Educ. 2018 Mar-Apr;75(2):434-441. doi: 10.1016/j.jsurg.2017.08.012. Epub 2017 Oct 12.
PubMed 28923535
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Learning Curve of Digital Rectal Examination for Prostate Cancer Among Internship
- ClinicalTrials.gov ID
- NCT03479359
- Acronym / sponsor ID
- CH-Urology-DRE-001
- Keywords
- Prostate cancer; Benign Prostatic Hyperplasia; Digital Rectal Examination; Accuracy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- 26 Feb 2018 (actual)
- Primary completion
- 26 Feb 2019 (estimated)
- Study completion
- 26 Feb 2019 (estimated)
- First posted
- 27 Mar 2018 (actual)
- 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.
The investigators conduct this prospective study to investigate the learning curve of digital rectal examination (DRE) for prostate cancer among internship. The investigators want to know how many DRE are usually needed for internship to be performed in urological practice to obtain a stable DRE accuracy.
Detailed description
Digital rectal examination (DRE) is a basic physical examination in routine practice in Urology. The DRE is a very important daily practice for screen prostate cancer, and each internship in Urology is required to perform this for patients suspected of prostate cancer or benign prostate hyperplasia. However, how many DRE are usually needed for a internship to perform so as to obtain a stable accuracy in daily practice is currently unknown. The investigators thus conduct this prospective trial to investigate the learning curve of DRE among internship.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Behavioral: Routine review of DRE results by attending doctorsIn this group, internship are given the pathology outcome of each prostate biopsy regularly twice a month. |
| Group 2 | – | –In this group, internship are not given the pathology outcome of each prostate biopsy. |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All included internship are graduated from the Second Military Medical University and have already get the M.D. degree
Key inclusion criteria (3 listed)
- Internship just graduate from the medical school, and agree to attend the study.
- Internship have less than 5 DREs of prostate cancer.
- Patients of any age who are included for prostate biopsy are eligible, the indications for prostate biopsy are as follows: PSA>4ng/ml, fPSA/tPSA<0.16, with suspected palpable nodes in the prostate by DRE of attending doctor, suspected mass in prostate detected by ultrasound examination, magnetic resonance imaging, or computed tomography.
Key exclusion criteria (2 listed)
- Internship who are not willing to attend the study.
- Internship stop doing DRE for continuously 3 months after entering the study.
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 |
|---|---|---|
| Routine review of DRE results by attending doctorsLet the internship regularly compare DRE result and the pathology outcome of prostate biopsy of each patient. | Behavioural | Group 1 |
Primary outcome
Sensitivity and specificity of DRE performed by internship will be confirmed by prostate biopsy
Time frame: One year
To examine the sensitivity and specificity of the DRE performed by internship to reference standard of prostate biopsy in a prospective longitudinal cohort of around 700 participants who will undergo prostate biopsy due to suspect of prostate cancer. The investigators will investigate the sensitivity and specificity of DRE by different internship monthly.
2 secondary outcomes
Sensitivity and specificity of DRE performed by internship with different training plan will be confirmed by prostate biopsy
Time frame: One year
Sensitivity and specificity of DRE performed by internship will be compared to the results of fPSA/tPSA and MRI.
Time frame: One year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2018.
- Background: PubMed 29061540Halpern JA, Oromendia C, Shoag JE, Mittal S, Cosiano MF, Ballman KV, Vickers AJ, Hu JC. Use of Digital Rectal Examination as an Adjunct to Prostate Specific Antigen in the Detection of Clinically Significant Prostate Cancer. J Urol. 2018 Apr;199(4):947-953. doi: 10.1016/j.juro.2017.10.021. Epub 2017 Oct 20.
- Background: PubMed 28923535Clements MB, Schmidt KM, Canfield SE, Gilbert SM, Khandelwal SR, Koontz BF, Lallas CD, Liauw S, Nguyen PL, Showalter TN, Trabulsi EJ, Cathro HP, Schenkman NS, Krupski TL. Creation of a Novel Digital Rectal Examination Evaluation Instrument to Teach and Assess Prostate Examination Proficiency. J Surg Educ. 2018 Mar-Apr;75(2):434-441. doi: 10.1016/j.jsurg.2017.08.012. Epub 2017 Oct 12.
- Individual participant dataSharing planned: Yes. IPD will be shared after the results of the study has been published. Related information will be given if request by email is agreed by the principle investigator.
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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.
Chuanliang Xu, M.D., Ph.D principal investigator
Second Military Medical University
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 Digital Rectal Examination, run by Changhai Hospital 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 3 inclusion and 2 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 27 Mar 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 Shuxiong Zeng, M.D., Ph.D (+86 18930568759, zengshuxiong@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and specificity of DRE performed by internship will be confirmed by prostate biopsy (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03479359, which also lists 2 linked publications.
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 27 Mar 2018.