ProteomicsNCT05289895
Prognostic Biomarkers of Pancreatic Cancer Based on Proteomic Techniques
An observational study of Proteomics and Pancreatic Cancer, run by The Affiliated Hospital of Qingdao University.
Trial summary
Sequence I (Retrospective study: proteomic analysis of pathological specimens and information collection of previous patients with pancreatic cancer) Sequence 2 (Non-interventional prospective study, sample and information collection in patients with pancreatic cancer) Sequence 3 (Non-intervention study, healthy… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Proteomics, Pancreatic Cancer, Prognostic Biomarkers
- How many people
- 220 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2022to 30 Dec 2024
- 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
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Healty Chinese volunteers and Pancreatic cancer patients
Who may be able to join
- Sequence 1 (pathological specimens and information collection of pancreatic cancer patients):
- Chinese patients, regardless of age and gender;
- patients with pancreatic cancer confirmed by pathology;
- Patients without a second primary tumor;
- The clinical diagnostic information to be collected within three months before sampling is relatively complete.
- Sequence 2 (samples and information collection of patients with pancreatic cancer):
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- Chinese patients, regardless of age and gender;
- Subjects must obtain informed consent and sign informed consent, indicating that they understand the purpose and procedure of this study and are willing to participate in the study;
- Patients with pancreatic malignancy diagnosed by pathology;
- Patients without a second primary tumor.
- Sequence 3 (healthy subject samples and information collection)
- Chinese healthy male or female, aged 18-45;
- Subjects must obtain informed consent and sign informed consent, indicating that they understand the purpose and procedure of this study and are willing to participate in the study;
- Physical examination, vital signs, laboratory examination (blood routine, blood biochemistry and urine routine), 12 lead ECG and other normal or abnormal persons without clinical significance
Who cannot join
- Sequence 1 :
- The quality of pathological specimens of patients can not meet the requirements of proteomics;
- The researchers believe that patients who are not suitable for proteomic analysis.
- Sequence 2:
- patients with other malignant tumors (non pancreatic cancer metastasis).
- hepatitis B surface antigen positive, hepatitis C antibody positive, HIV antibody positive or syphilis antibody positive;
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- Pregnant or lactating women;
- The researcher believes that it is not suitable to participate in this experiment.
- Sequence 3:
- Abnormalities of clinical significance judged by clinicians, including physical examination, vital signs examination, ECG or clinical laboratory examination results;
- hepatitis B surface antigen positive, hepatitis C antibody positive, HIV antibody positive or syphilis antibody positive;
- Those who have participated in other clinical trials of drugs and accepted clinical trials of drugs or devices for trial within the first three months;
- Those vaccinated with active or attenuated vaccine within 1 month before screening or during the planned trial;
- Pregnant or lactating women;
- Those who have taken any drugs within the first 14 days;
- The researcher believes that it is not suitable to participate in this experiment.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Clinical Study on Prognostic Biomarkers of Pancreatic Cancer Based on Proteomic Technique
Sequence I (Retrospective study: proteomic analysis of pathological specimens and information collection of previous patients with pancreatic cancer) Sequence 2 (Non-interventional prospective study, sample and information collection in patients with pancreatic cancer) Sequence 3 (Non-intervention study, healthy subjects sample and information collection)
Read the detailed description
Sequence 1 was a retrospective study, which collected pathological tissue samples (continuous cut white slices, 10 slices per case, 2 of which were HE stained slices) and clinical data (including clinical diagnostic information, laboratory examination results, imaging findings, and prognosis information) from 100 patients with pancreatic cancer. Proteomic analysis was performed on the samples. Sequence 2 was a non-intervention prospective study, which would collect pathological tissue samples (continuous cut white slices, 10 slices per case, 2 of which were hematoxylin-eosin staining (HE) stained slices) , blood (4ml ) and urine (5mL) samples from 100 subjects with pancreatic cancer before medication. The pathological samples and clinical information of the subjects were collected for proteomic analysis. Sequence 3 was a non-intervention study, which would collect blood (4ml ) and urine (5mL) samples from 20 healthy subjects (as control samples for proteomic analysis)
- Conditions
- Proteomics, Pancreatic Cancer, Prognostic Biomarkers
- Being tested
- No intervention
- Keywords
- proteomics, Pancreatic Cancer, Prognostic Biomarkers
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
This study was an observational trial without any intervention
| Study group | Role | What they receive |
|---|---|---|
| 1 | Sequence I (Retrospective study: proteomic analysis of pathological specimens and information collection of previous patients with pancreatic cancer) Receives: Other: No intervention | |
| 2 | Sequence 2 (Non-interventional prospective study, sample and information collection in patients with pancreatic cancer) Receives: Other: No intervention | |
| 3 | Sequence 3 (Non-intervention study, healthy subjects sample and information collection) Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proteomic analysis of tumor tissue samples
Proteomic analysis of tumor tissue samples from patients with pancreatic cancer
Measured: 2 years
Proteomic analysis of blood and urine
Proteomic analysis of blood and urine in healthy volunteers and patients with pancreatic cancer
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2022
- Study start1 Apr 2022 (estimated)
- Primary completion1 Mar 2023 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ProteomicsStudies of the same condition, open and under way.
- More trials run by The Affiliated Hospital of Qingdao UniversityThe 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
- Other
- Time perspective
- Other
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital of Qingdao University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05289895
- Sponsor's protocol ID
- JJDB-SR-2021-04
- Status last verified
- Mar 2022
- First submitted
- 6 Mar 2022
- Last updated
- 22 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This study is confidential. All the technical achievements and outcomes of this trial are owned by the Affiliated Hospital of Qingdao University and two two cooperative research organization.
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on Prognostic Biomarkers of Pancreatic Cancer Based on Proteomic Technique
- ClinicalTrials.gov ID
- NCT05289895
- Acronym / sponsor ID
- JJDB-SR-2021-04
- Conditions
- Proteomics, Pancreatic Cancer, Prognostic Biomarkers
- Keywords
- proteomics, Pancreatic Cancer, Prognostic Biomarkers
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- The Affiliated Hospital of Qingdao UniversityUniversity, hospital or other
- Study start
- 1 Apr 2022 (estimated)
- Primary completion
- 1 Mar 2023 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 22 Mar 2022 (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.
Sequence I (Retrospective study: proteomic analysis of pathological specimens and information collection of previous patients with pancreatic cancer) Sequence 2 (Non-interventional prospective study, sample and information collection in patients with pancreatic cancer) Sequence 3 (Non-intervention study, healthy subjects sample and information collection)
Detailed description
Sequence 1 was a retrospective study, which collected pathological tissue samples (continuous cut white slices, 10 slices per case, 2 of which were HE stained slices) and clinical data (including clinical diagnostic information, laboratory examination results, imaging findings, and prognosis information) from 100 patients with pancreatic cancer. Proteomic analysis was performed on the samples. Sequence 2 was a non-intervention prospective study, which would collect pathological tissue samples (continuous cut white slices, 10 slices per case, 2 of which were hematoxylin-eosin staining (HE) stained slices) , blood (4ml ) and urine (5mL) samples from 100 subjects with pancreatic cancer before medication. The pathological samples and clinical information of the subjects were collected for proteomic analysis. Sequence 3 was a non-intervention study, which would collect blood (4ml ) and urine (5mL) samples from 20 healthy subjects (as control samples for proteomic analysis)
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Other: No interventionSequence I (Retrospective study: proteomic analysis of pathological specimens and information collection of previous patients with pancreatic cancer) |
| 2 | – | Other: No interventionSequence 2 (Non-interventional prospective study, sample and information collection in patients with pancreatic cancer) |
| 3 | – | Other: No interventionSequence 3 (Non-intervention study, healthy subjects sample and information collection) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Healty Chinese volunteers and Pancreatic cancer patients
Key inclusion criteria (14 listed)
- Sequence 1 (pathological specimens and information collection of pancreatic cancer patients):
- Chinese patients, regardless of age and gender;
- patients with pancreatic cancer confirmed by pathology;
- Patients without a second primary tumor;
- The clinical diagnostic information to be collected within three months before sampling is relatively complete.
Key exclusion criteria (16 listed)
- The quality of pathological specimens of patients can not meet the requirements of proteomics;
- The researchers believe that patients who are not suitable for proteomic analysis.
- patients with other malignant tumors (non pancreatic cancer metastasis).
- hepatitis B surface antigen positive, hepatitis C antibody positive, HIV antibody positive or syphilis antibody positive;
- Pregnant or lactating women;
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 |
|---|---|---|
| No interventionThis study was an observational trial without any intervention | Other | 1, 2, 3 |
Primary outcome
Proteomic analysis of tumor tissue samples
Time frame: 2 years
Proteomic analysis of tumor tissue samples from patients with pancreatic cancer
Proteomic analysis of blood and urine
Time frame: 1 year
Proteomic analysis of blood and urine in healthy volunteers and patients with pancreatic cancer
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2022.
- Individual participant dataSharing planned: No. This study is confidential. All the technical achievements and outcomes of this trial are owned by the Affiliated Hospital of Qingdao University and two two cooperative research organization.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Proteomics and Pancreatic Cancer, run by The Affiliated Hospital of Qingdao University.
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 14 inclusion and 16 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 22 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
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 Yu Cao, Professor (86-18661809090, caoyu1767@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proteomic analysis of tumor tissue samples (time frame: 2 years). The study lists 2 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 22 Mar 2022.