Ignite Creation Date:
2025-12-24 @ 10:01 PM
Ignite Modification Date:
2025-12-28 @ 11:27 PM
Study NCT ID:
NCT04440332
Status:
UNKNOWN
Last Update Posted:
2020-06-19
First Post:
2020-06-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Surveillance of Peripheral Blood of Lymphocyte and Immunocyte in Neoadjuvant Therapy Patients With Esophageal Squamous Cell Carcinoma (pLINE)
Sponsor:
Sichuan Cancer Hospital and Research Institute
Organization:
Study Overview
Official Title:
The Clinical Significance of Surveillance of Lymphocyte and Immunocyte Subsets in Peripheral Blood of Esophageal Squamous Cell Carcinoma Patients With Neoadjuvant Chemoradiotherapy Combine Surgery or Surgery Alone (pLINEļ¼.
Status:
UNKNOWN
Status Verified Date:
2020-06
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Neoadjuvant chemoradiotherapy treatment represents the standard approach for resectable locally advanced esophageal squamous cell carcinoma. The incidence of pulmonary infection and other perioperative complications were higher in patients who received esophagectomy and neoadjuvant chemoradiotherapy than those without neoadjuvant treatment and surgery patients. However, reliable clinical data can quantify the damage degree of immunologic function caused by chemotherapy and radiotherapy is still unknown. This project regards the level of lymphocyte and immunocyte in peripheral blood as a quantitative index to reflect the dynamic change of the immunologic function of patients with locally advanced esophageal squamous cell carcinoma after neoadjuvant chemoradiotherapy treatment. Meanwhile, the investigators will also investigate the relationship between the level of lymphocyte and immunocyte in peripheral blood and the response rate of neoadjuvant therapy.
Detailed Description:
Peripheral blood will be collected from patients who will undergo esophagectomy and/or neoadjuvant therapy. The setting time is before chemoradiotherapy, finishing chemoradiotherapy, pre-operation, postoperative day 1, day 3, day 5, and day 7. These blood samples will be used for detection and analysis in lymphocyte and immunocyte by flow cytometry.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: