Prognostic Biomarkers of Pancreatic Cancer Based on Proteomic Techniques

NCT05289895 | Unknown

• 1 other identifier: JJDB-SR-2021-04
• Study Type: observational
• Target: 220
• Locations: 0 countries
• Sites: N/A

Brief 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 subjects sample and information collection)

Conditions

Proteomics; Pancreatic Cancer; Prognostic Biomarkers

Keywords

proteomics; Pancreatic Cancer; Prognostic Biomarkers

Outcome Measures

Primary Outcomes (2)

• Proteomic analysis of tumor tissue samples

  Proteomic analysis of tumor tissue samples from patients with pancreatic cancer

  2 years

• Proteomic analysis of blood and urine

  Proteomic analysis of blood and urine in healthy volunteers and patients with pancreatic cancer

  1 year

Study Arms (3)

1

Sequence I (Retrospective study: proteomic analysis of pathological specimens and information collection of previous patients with pancreatic cancer)

Other: No intervention

2

Sequence 2 (Non-interventional prospective study, sample and information collection in patients with pancreatic cancer)

Other: No intervention

3

Sequence 3 (Non-intervention study, healthy subjects sample and information collection)

Other: No intervention

Interventions

No intervention OTHER

This study was an observational trial without any intervention

1; 2; 3

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healty Chinese volunteers and Pancreatic cancer patients

You may qualify if:

• 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):
• 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

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• The Affiliated Hospital of Qingdao University: lead

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Central Study Contacts

Yu Cao, Professor

CONTACT

86-18661809090; caoyu1767@126.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2022
• First Posted: March 22, 2022
• Study Start: April 1, 2022
• Primary Completion: March 1, 2023
• Study Completion: December 30, 2024
• Last Updated: March 22, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share