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Trial Title:
Development and Clinical Validation of Early-stage Lung Cancer Prognostic Kit
NCT ID:
NCT05557474
Condition:
Lung Cancer
Surgery
Recurrence
Conditions: Official terms:
Lung Neoplasms
Recurrence
Conditions: Keywords:
Lung Cancer
Immunohistochemistry
Enzyme-linked Immunosorbent Assay
Laboratory developed tests
Recurrence
Study type:
Observational [Patient Registry]
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
Early-stage lung cancer prognostic kit -- ELISA
Description:
blood sample with ELISA
Arm group label:
Lung cancer post surgery recurrence follow up
Intervention type:
Other
Intervention name:
Early-stage lung cancer prognostic kit -- IHC
Description:
surgical tumor part with IHC
Arm group label:
Lung cancer post surgery recurrence follow up
Summary:
Lung cancer is the leading cause of cancer mortality worldwide in spite of the advanced
progresses in medication and low-dose CT screening. The early-stage lung cancer accounts
for less than 50% of newly diagnosed lung cancer in Taiwan, even in stage IB patients
proximately 30% still suffer from recurrence and metastasis.
The International Cancer Moonshot Project recently established the first comprehensive
proteogenomics profiling of early-stage lung cancer patients in East Asia, revealing a
proteomics-informed classification to identify a new "late like" subtype, which can
identify a subgroup of early-stage patients with worse clinicopathological features
(Cell, Cover story, 2020). This study has been featured in prestigious journals (Nat Rev
Clin Oncol; Cancer Discov, 2020) and led to two provisional US patents. In this proposal,
taking the discovery from the Cancer Moonshot multiomics database, the investigators aim
to translate these findings into clinical utilities. Two subprojects are proposed. (1)
Validation of "late-like" protein markers for identifying high-risk early-stage lung
cancer: Two IVD kits will be developed, including high-risk early-stage lung cancer IHC
prediction kit for tumor staining and high-risk early lung cancer ELISA prediction kit
for noninvasive diagnosis. (2) Conducting a prospective clinical trial to evaluate the
accuracy of high-risk early-stage lung cancer IHC prediction kit and high-risk
early-stage lung cancer ELISA prediction kit.
Criteria for eligibility:
Study pop:
Early stage lung adenocarcinoma post-surgical follow up
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- Willing to sign and provide subject consent.
- Male or female of age 20 or older.
- Patients diagnosed with lung adenocarcinoma by tumor pathology.
- Lung cancer with the pathological stage of IA/IB/II/IIIA according to the American
Joint Committee on Cancer Staging Manual (8th Edition).
- Complete tumor resection (R0 resection).
- The East Coast Cancer Clinical Research Collaborative (ECOG) performance status was
0 or 1 at the time of grouping.
- Those willing to provide tumor tissue or cytology specimens (including surgical
specimens, tissue biopsy specimens, or cytology specimens), blood and body fluid
specimens (for follow-up or disease recurrence, such as urine, malignant pleural
effusion, ascites, pericardial fluid, etc.).
Exclusion Criteria:
- Not primary lung cancer patients.
- Lung cancer patients whose pathological stage is not IA/IB/II/IIIA according to the
American Joint Committee on Cancer Staging Manual (8th Edition) after surgery.
- Patients with uncontrolled malignant tumors other than lung cancer.
- Uncontrolled systemic disease (such as diabetes, hypertension, active infection,
etc.) (determined by the principal investigator )
- Pregnant women.
- Any condition may put the patient at serious risk, may affect the interpretation of
the trial results, or may seriously interfere with the patient's participation in
the trial.
Gender:
All
Minimum age:
20 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Chung Shan Medical University Hospital
Address:
City:
Taichung
Zip:
402
Country:
Taiwan
Status:
Recruiting
Contact:
Last name:
GEECHEN CHANG, MD, PhD
Phone:
+886-4-24739595
Phone ext:
34414
Email:
geechen@gmail.com, cshy1888@csh.org.tw
Facility:
Name:
National Taiwan University, Cancer Center
Address:
City:
Taipei
Zip:
106
Country:
Taiwan
Status:
Recruiting
Contact:
Last name:
Jin-Shing Chen, MD PhD
Start date:
October 1, 2021
Completion date:
December 31, 2028
Lead sponsor:
Agency:
Chung Shan Medical University
Agency class:
Other
Collaborator:
Agency:
National Science and Technology Council
Agency class:
U.S. Fed
Source:
Chung Shan Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05557474
