MedDataX Logo

A Clinico-Pathological Study to Investigate the Possible Infective Causes of Non-Hodgkin Lymphoma of the Ocular Adnexae

NCT ID: NCT01010295

Last Updated: 2013-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2012-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Patients with mucosa-associated lymphoid tissue (MALT) lymphoma of the ocular adnexae (MLOA) will be eligible for treatment with doxycycline (part A: clinico-pathological study); patients with other types of ocular lymphoma, inflammatory lesions or those ineligible/unwilling for treatment with doxycycline can participate in the only pathologic study (part B).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Patients with suspected lymphoma of the ocular adnexae will undergo a diagnostic biopsy in the usual way. If lymphoma is confirmed the patient will undergo a full staging evaluation and entry into either part A or B of the study will then be considered as follows:

* clinico-pathological (part A) for patients with MALT lymphoma of the ocular adnexae (MLOA) and eligible for treatment with Doxycycline 100 mg twice daily for 3 weeks ; or
* pathology only (part B) for patients with other types of ocular lymphoma, inflammatory lesions or those ineligible/unwilling for treatment with doxycycline.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Non-Hodgkin Lymphoma

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

NHL of the ocular adnexae

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

doxycycline

doxycycline 100 mg twice daily for 3 weeks

Group Type EXPERIMENTAL

doxycycline (tetracycline)

Intervention Type DRUG

doxycycline 100 mg twice daily for 3 weeks

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

doxycycline (tetracycline)

doxycycline 100 mg twice daily for 3 weeks

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Age 18 years or over
2. Histologically confirmed marginal zone B-cell lymphoma of MALT-type
3. Lymphoma localised to the ocular adnexae (conjunctiva, lacrimal gland, orbit soft tissue, clinical stage IEA) following a CT scan of neck, thorax, abdomen and pelvis, bone marrow aspirate/trephine, full blood count and biochemical profile
4. No previous treatment, excepting RT for localised lymphoma of the contralateral eye
5. At least one measurable lesion
6. No systemic antibiotic therapy in the last three months
7. No other malignancy in the previous 5 years apart from appropriately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix
8. In women with reproductive potential a willingness to use contraception from entry into the study for a period of 3 months
9. Written informed consent

Exclusion Criteria

1. Pregnant or lactating women
2. Known allergy to tetracycline
3. Patients unwilling to comply with the requirements of follow-up as defined by this protocol
4. Myasthenia gravis (tetracycline can exacerbate muscle weakness)
5. Systemic lupus erythematous (tetracycline can exacerbate the condition)
6. Patients with large or rapidly enlarging tumours requiring immediate radiotherapy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

International Extranodal Lymphoma Study Group (IELSG)

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Andrés JM Ferreri, MD

Role: STUDY_CHAIR

International Extranodal Lymphoma Study Group

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hospital del Salvador

Providencia, Santiago, , Chile

Site Status

Ospedale San Raffaele, Department of Oncology

Milan, Milan, Italy

Site Status

S. Matteo

Pavia, , Italy

Site Status

A.O. Bianchi-Melacrino-Morelli, Divisione di Ematologia

Reggio Calabria, , Italy

Site Status

Hospital Ramon y Cajal

Madrid, , Spain

Site Status

IOSI

Bellinzona, , Switzerland

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Chile Italy Spain Switzerland

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

EudraCT number 2006-005795-41

Identifier Type: -

Identifier Source: secondary_id

IELSG27

Identifier Type: -

Identifier Source: org_study_id