Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2026-01-07 @ 6:28 AM
Study NCT ID:
NCT06435767
Status:
RECRUITING
Last Update Posted:
2024-05-30
First Post:
2024-05-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Quantitative Nodal Burden as a Determinant Identifying Ampullary Adenocarcinoma Patients Benefiting From Adjuvant Chemotherapy
Sponsor:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Organization:
Study Overview
Official Title:
Quantitative Nodal Burden as a Determinant Identifying Ampullary Adenocarcinoma Patients Benefiting From Adjuvant Chemotherapy: A Retrospective Cohort Study
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
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:
Ampullary cancer, a rare malignancy, lacks standardized guidelines for effective multimodal treatment following curative resection. The opinions on whether postoperative chemotherapy can improve the long-term survival of ampullary adenocarcinoma (AA) are discordant. This aspect remains poorly studied, with comparably scant research conducted on it.
log odds of positive lymph nodes (LODDS), a quantitative variable, can continuously and accurately reflect the burden of nodal involvement, which suggested a potential ability to identify AA patients benefiting from postoperative adjuvant chemotherapy (ACT). Therefore, Mainly focused issues of ACT addressed in the study are as follows: 1) the role of ACT in improving long-term survival for patients with AA after curative resection. 2) the role of LODDS in identifying postoperative AA patients benefiting from ACT. 3) compared with T and N classifications reported previously, the advantage of LODDS in identifying ACT-benefited patients.
In this cohort study, a large scale of sample size was conducted by drawing on the collective experience of the National Cancer Center of China. The patients treated with radiotherapy were excluded to concentrate on the effect of ACT.
log odds of positive lymph nodes (LODDS), a quantitative variable, can continuously and accurately reflect the burden of nodal involvement, which suggested a potential ability to identify AA patients benefiting from postoperative adjuvant chemotherapy (ACT). Therefore, Mainly focused issues of ACT addressed in the study are as follows: 1) the role of ACT in improving long-term survival for patients with AA after curative resection. 2) the role of LODDS in identifying postoperative AA patients benefiting from ACT. 3) compared with T and N classifications reported previously, the advantage of LODDS in identifying ACT-benefited patients.
In this cohort study, a large scale of sample size was conducted by drawing on the collective experience of the National Cancer Center of China. The patients treated with radiotherapy were excluded to concentrate on the effect of ACT.
Detailed Description:
None
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?: