Ignite Creation Date:
2024-05-06 @ 3:49 AM
Last Modification Date:
2024-10-26 @ 11:39 AM
Study NCT ID:
NCT02388581
Status:
RECRUITING
Last Update Posted:
2016-03-25
First Post:
2014-12-04
Brief Title:
First-line Antibiotic Therapy for Early-stage HP Gastric Pure DLBCL
Sponsor:
National Health Research Institutes Taiwan
Organization:
National Health Research Institutes Taiwan
Study Overview
Official Title:
Multicentre Prospective Study of First-line Antibiotic Therapy for Early-stage H Pylori-Positive Gastric Pure de Novo Diffuse Large B-cell Lymphoma and Potential Predicting Factor for Treatment Outcome
Status:
RECRUITING
Status Verified Date:
2015-12
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:
Aims A nationwide study to prospectively validate
1 The complete histological and molecular remission rate for antibiotics as 1st-line therapy for early-stage Hp-positive gastric pure de novo DLBCL
2 The durability of complete histological remission after antibiotics
3 The usefulness of pattern of NF-kB BCL10 BAFF and CagA by IHC staining in prospectively predicting the Hp-dependence of gastric pure de novo DLBCL
4 The frequency of t1118q21q21 translocation in gastric pure de novo DLBCL in Taiwan
5 The association between the CYP2C18CYP2C19 genetic polymorphisms and eradication of Hp infection after antibiotics
1 The complete histological and molecular remission rate for antibiotics as 1st-line therapy for early-stage Hp-positive gastric pure de novo DLBCL
2 The durability of complete histological remission after antibiotics
3 The usefulness of pattern of NF-kB BCL10 BAFF and CagA by IHC staining in prospectively predicting the Hp-dependence of gastric pure de novo DLBCL
4 The frequency of t1118q21q21 translocation in gastric pure de novo DLBCL in Taiwan
5 The association between the CYP2C18CYP2C19 genetic polymorphisms and eradication of Hp infection after antibiotics
Detailed Description:
The study will validate the use of antibiotics as first-line therapy for stage IE and perhaps IIE-1 Hp-positive gastric pure de novo DLBCL The status of NF-kB BCL10 BAFF and CagA IHC nuclear staining will help to tailoring the treatment for early-stage gastric pure de novo DLBCL And 50-60 of stage IE IIE-1 pure de novo DLBCL patients can be cured by 2-weeks of antibiotics rather than the 6-months of relatively toxic front-line systemic chemotherapy The investigators shall also elucidate the distribution of CYP2C1819 in patients with pure de novo DLBCL and their association with the efficacy of sequential antibiotics for eradication of Hp infection
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None