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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06339307
Other study ID # DJY004
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 15, 2024
Est. completion date December 31, 2024

Study information

Verified date February 2024
Source Tianjin Medical University Cancer Institute and Hospital
Contact Jingyu Deng, M.D.
Phone +86-22-23340123
Email dengery@126.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

In our prior research, a risk scoring model for the occurrence of lymph node metastasis in patients who underwent radical gastrectomy for gastric cancer was established. To further validate this scoring model, a prospective study has been designed with the aim of prospectively assessing the model's clinical applicability.


Description:

The study was a single-centre, prospective study. Data prospectively accrued were employed to evaluate the concordance between observed patient outcomes, with respect to lymph node metastasis status post-curative gastrectomy, and the prognostications tendered by the established risk scoring model, thereby appraising the model's clinical applicability and validity.


Recruitment information / eligibility

Status Recruiting
Enrollment 120
Est. completion date December 31, 2024
Est. primary completion date June 30, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: 1. Primary gastric adenocarcinoma; 2. Curative surgery (with R0 resection, excluding palliative surgery and cases with distant metastasis). Exclusion Criteria: 1. Patients with autoimmune diseases, inflammation, or hematological disorders; 2. Patients with a history of or concurrent other cancers; 3. Presence of active infection and inflammation (based on WBC count, patients with count of 10×10^9 or higher should be evaluated through medical record examination for the presence of infection); 4. Active bleeding (as determined by endoscopic ultrasound and HGB = 90); 5. Post neoadjuvant radiotherapy or chemotherapy; 6. History of blood transfusion, corticosteroid use, or leukocyte-stimulating medications within the past month prior to blood draw; 7. Incomplete clinical and pathological data.

Study Design


Locations

Country Name City State
China Cancer Hospital of Tianjin Medical University Tianjin Tianjin

Sponsors (1)

Lead Sponsor Collaborator
Tianjin Medical University Cancer Institute and Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary lymph node metastasis Collect postoperative pathological data from gastric cancer patients who have undergone curative gastrectomy to determine the occurrence of lymph node metastasis. 1 month after curative surgery
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