Mucosa-Associated Lymphoid Tissue LymphomaNCT02987127
Prospective Study of Frontline H Pylori Eradication in the Treatment of Early-stage Extragastric MALT Lymphoma
An observational study of Mucosa-Associated Lymphoid Tissue Lymphoma, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Gastric low-grade mucosa-associated lymphoid tissue lymphoma (MALToma) is associated with Helicobacter pylori (HP) infection, and around 70% of these tumors can be cured by HP eradication therapy (HPE). However, the role of antibiotics in the frontline treatment of extragastric MALToma remains unclear. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Mucosa-Associated Lymphoid Tissue Lymphoma
- How many people
- 21 participants
- Where
- 1 siteTaiwan
- Study dates
- Feb 2016to Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Extragastric mucosa-associated lymphoid tissue lymphoma
Who may be able to join
- The patients must have histologically confirmed low-grade mucosa-associated
- lymphoid tissue lymphoma of extragastric sites.
- Patients must have evaluable disease by physical examination, endoscopy (also include colonfibroscopy, and bronchoscopy) or computed tomography.
- Patients must receive examination of documented HP infection or not before treatment, which will be evaluated by the following tests: histology, rapid urease test (CLO-test), C-13 urease breath test and serology.
- Patients must have either stage IE or IIE-1 disease, according to an adaptation of the Ann Arbor staging system modified by Musshoff for primary extranodal lymphoma.
- Patients must have signed the informed consent and agree to provide achieved pathologic material for immunohistochemical staining of BCL10, NF-KB, BAFF, CagA, CagA-signaling molecules, for fluorescence in situ hybridization study for t(11;18)(q21;q21)/API2-MALT1 and t(14;18)(q32;q21)/IGH-MALT1 determination, and for PCR of Chlamydia psittaci and Borrelia burgdorferi.
- Patients must have signed the informed consent and agree to provide achieve blood samples for CYP2C19 genetic polymorphisms evaluation and potential serum molecular studies, such as serum BAFF level
Who cannot join
- In the diagnosis of the disease over the past five years with a history of other cancers but non-melanoma skin cancer, breast and cervical carcinoma in situ carcinoma in situ (leafy or tubular) can still meet the conditions of admission to this case study
- Patients receiving chemotherapy or radiotherapy of nodules outside the low-grade malignant lymphoma, but has not yet been cured, the excluded
- The second more, and not in the lymph nodes adjacent to the tumor (IIE-2 period or more), the excluded
- The state can not afford this clinical cardiopulmonary ㄧ inspection after the test series, the excluded
- suffering from primary gastric outside MALToma before and had received chemotherapy or radiation therapy in patients of.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, Taipei, 100
Sung-Hsin Kuo, M.D.,Ph.D, +886-2-23123456 ext. 67144, shkuo101@ntu.edu.tw
Shu-Ling Wu, MS, +886-2-23123456 ext. 67573, shulingwu.ntuh@gmail.com
About this study
Official title: Prospective Study of Frontline Helicobacter Pylori Eradication Therapy in the Treatment of Early-stage Extragastric Mucosa-associated Lymphoid Tissue Lymphoma
Gastric low-grade mucosa-associated lymphoid tissue lymphoma (MALToma) is associated with Helicobacter pylori (HP) infection, and around 70% of these tumors can be cured by HP eradication therapy (HPE). However, the role of antibiotics in the frontline treatment of extragastric MALToma remains unclear. In addition to anecdotal case reports showing histologic regression of extragastric MALTomas after antibiotics, our explorative study found that frontline HPE (clarithromycin, amoxicillin, and omeprazole) resulted in complete remission (CR) in this subgroup patients (2 salivary gland, 1 lung, 1 colon, and 4 ocular adnexal MALToma [OAML]). Interestingly, two patients with OAML who do not respond to Chlamydia psittaci (CP) eradication using doxycycline achieved CR after HPE. These findings suggest that bacterial infections, including HP, may be involved in the lymphomagenesis of these extragastric MALTomas. Our preliminary results also revealed that 5 (23.8%) of 21 HP-negative gastric MALToma patients achieved CR after HPE, indicating that antibiotics may also have ability to eradicate non-HP bacteria. Based on our preliminary findings and the indolent biologic behavior of MALToma, it is reasonable to use frontline HPE in the treatment of early-stage low-grade extragastric MALToma.
Read the detailed description
Through a prospective trial of frontline HPE in the treatment of early-stage extragastric MALToma, investigators will evaluate and investigate the following issues:
- The CR and partial remission (PR) rate for antibiotics as 1st-line therapy for stage IE and stage IIE extragastric MALToma
- The durability of CR and PR (relapse-free survival) after antibiotics treatment (HPE) in early-stage extragastric MALToma
- The assessment of the evidence of bacterial infection, such as HP, in extragastric MALToma.
- The identification of potential biomarkers that help us predict whether extragastric MALToma can respond to frontline HPE.
- Medical subject headings
- Lymphoma, B-Cell, Marginal Zone
What is being measured
The primary outcome is the main question the study is designed to answer.
The complete and partial remission rate for antibiotics as 1st-line therapy for stage IE-IIE1 extragastric MALT lymphoma.
The complete remission rate and partial remission rate for antibiotics (HP eradicaiton) as 1st-line therapy for early-stage extragastric MALT lymphoma
Measured: 5 years
Secondary outcomes (4)
The overall survival of early-stage extragastric MALT lymphoma patients who received frontline HP eradication therapy
Measured: 5 years
The assessment of the evidence of bacterial infection in all extragstric MALT lymphoma
Measured: 5 years
The usefulness of pattern of NF-κB, BCL10, BAFF, API2-MALT1, and IgH-MALT1 by IHC staining or FISH in prospectively predicting the antibiotics responsiveness of extragastric MALT lymphoma
Measured: 5 years
The relapse-free survival of early-stage extragastric MALT lymphoma patients who received antibiotics as 1st-line therapy
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2016 (estimated)
- Study startFeb 2016
- Primary completionSep 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mucosa-Associated Lymphoid Tissue LymphomaStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sung-Hsin Kuo, M.D.,Ph.D, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02987127
- Sponsor's protocol ID
- 201511025MINC
- Status last verified
- Dec 2016
- First submitted
- 1 Dec 2016
- Last updated
- 8 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study of Frontline Helicobacter Pylori Eradication Therapy in the Treatment of Early-stage Extragastric Mucosa-associated Lymphoid Tissue Lymphoma
- ClinicalTrials.gov ID
- NCT02987127
- Acronym / sponsor ID
- 201511025MINC
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Sep 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 8 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Gastric low-grade mucosa-associated lymphoid tissue lymphoma (MALToma) is associated with Helicobacter pylori (HP) infection, and around 70% of these tumors can be cured by HP eradication therapy (HPE). However, the role of antibiotics in the frontline treatment of extragastric MALToma remains unclear. In addition to anecdotal case reports showing histologic regression of extragastric MALTomas after antibiotics, our explorative study found that frontline HPE (clarithromycin, amoxicillin, and omeprazole) resulted in complete remission (CR) in this subgroup patients (2 salivary gland, 1 lung, 1 colon, and 4 ocular adnexal MALToma [OAML]). Interestingly, two patients with OAML who do not respond to Chlamydia psittaci (CP) eradication using doxycycline achieved CR after HPE. These findings suggest that bacterial infections, including HP, may be involved in the lymphomagenesis of these extragastric MALTomas. Our preliminary results also revealed that 5 (23.8%) of 21 HP-negative gastric MALToma patients achieved CR after HPE, indicating that antibiotics may also have ability to eradicate non-HP bacteria. Based on our preliminary findings and the indolent biologic behavior of MALToma, it is reasonable to use frontline HPE in the treatment of early-stage low-grade extragastric MALToma.
Detailed description
Through a prospective trial of frontline HPE in the treatment of early-stage extragastric MALToma, investigators will evaluate and investigate the following issues:
- The CR and partial remission (PR) rate for antibiotics as 1st-line therapy for stage IE and stage IIE extragastric MALToma
- The durability of CR and PR (relapse-free survival) after antibiotics treatment (HPE) in early-stage extragastric MALToma
- The assessment of the evidence of bacterial infection, such as HP, in extragastric MALToma.
- The identification of potential biomarkers that help us predict whether extragastric MALToma can respond to frontline HPE.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Extragastric mucosa-associated lymphoid tissue lymphoma
Key inclusion criteria (7 listed)
- The patients must have histologically confirmed low-grade mucosa-associated
- lymphoid tissue lymphoma of extragastric sites.
- Patients must have evaluable disease by physical examination, endoscopy (also include colonfibroscopy, and bronchoscopy) or computed tomography.
- Patients must receive examination of documented HP infection or not before treatment, which will be evaluated by the following tests: histology, rapid urease test (CLO-test), C-13 urease breath test and serology.
- Patients must have either stage IE or IIE-1 disease, according to an adaptation of the Ann Arbor staging system modified by Musshoff for primary extranodal lymphoma.
Key exclusion criteria (5 listed)
- In the diagnosis of the disease over the past five years with a history of other cancers but non-melanoma skin cancer, breast and cervical carcinoma in situ carcinoma in situ (leafy or tubular) can still meet the conditions of admission to this case study
- Patients receiving chemotherapy or radiotherapy of nodules outside the low-grade malignant lymphoma, but has not yet been cured, the excluded
- The second more, and not in the lymph nodes adjacent to the tumor (IIE-2 period or more), the excluded
- The state can not afford this clinical cardiopulmonary ㄧ inspection after the test series, the excluded
- suffering from primary gastric outside MALToma before and had received chemotherapy or radiation therapy in patients of.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The complete and partial remission rate for antibiotics as 1st-line therapy for stage IE-IIE1 extragastric MALT lymphoma.
Time frame: 5 years
The complete remission rate and partial remission rate for antibiotics (HP eradicaiton) as 1st-line therapy for early-stage extragastric MALT lymphoma
4 secondary outcomes
The overall survival of early-stage extragastric MALT lymphoma patients who received frontline HP eradication therapy
Time frame: 5 years
The assessment of the evidence of bacterial infection in all extragstric MALT lymphoma
Time frame: 5 years
The usefulness of pattern of NF-κB, BCL10, BAFF, API2-MALT1, and IgH-MALT1 by IHC staining or FISH in prospectively predicting the antibiotics responsiveness of extragastric MALT lymphoma
Time frame: 5 years
The relapse-free survival of early-stage extragastric MALT lymphoma patients who received antibiotics as 1st-line therapy
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sung-Hsin Kuo, M.D.,Ph.D principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mucosa-Associated Lymphoid Tissue Lymphoma, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sung-Hsin Kuo, M.D.,Ph.D (+886-2-23123456 ext. 67144, shkuo101@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The complete and partial remission rate for antibiotics as 1st-line therapy for stage IE-IIE1 extragastric MALT lymphoma. (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2016.