The objectives of the study are the following: - To develop a treatment for uveal melanoma metastases. For this purpose, the following will be conducted:* To establish an European Biobank of (preferably matched) UM metastasis, primary tumor and…
ID
Source
Brief title
Condition
- Ocular neoplasms
- Ocular neoplasms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Genetic, molecular and immunologic characteristics of primary tumor, metastases
and peripheral blood of patients diagnosed with uveal melanoma.
Analysis of molecular and immunologic experimental therapies in in vitro and in
vivo models.
Secondary outcome
not applicable
Background summary
In recent years, improvements have been made in the local control of primary
uveal melanoma (UM) and treatment modalities have been developed which allow
preservation of the eye. However, despite these developments, there is still no
effective treatment for UM metastases.
The aim of this study is to facilitate the development of new treatment options
for metastasized UM. By analyzing a large collection of UM metastases and
corresponding primary UM and blood samples, genetic, molecular and immunologic
characteristics will be revealed as potential treatment targets. Moreover, the
usage of in vitro and in vivo models based on primary UM and metastasis tissue
will allow the evaluation of treatment efficacy.
In order to apply future therapies effectively, cases with a small tumor load
are more likely to respond well than cases with large tumors. One can imagine
that early detection of metastases will benefit the patient. It would be useful
to have properly validated bloodmarkers of metastasis, however, these still
have to be developed. Therefore, we will evaluate the sensitivity and
specificity of existing markers and try to identify new markers of metastasis.
Study objective
The objectives of the study are the following:
- To develop a treatment for uveal melanoma metastases. For this purpose, the
following will be conducted:
* To establish an European Biobank of (preferably matched) UM metastasis,
primary tumor and blood samples
* To analyze molecular characteristics of UM metastasis and corresponding
primary UM
* To characterize and evaluate anti-tumor activity of T cells in primary
tumors, metastases and blood of UM patients
* To establish in vitro and in vivo models for preclinical analysis
* To identify markers of metastasis in the patient*s blood
Study design
International multicentre observational study.
Primary tumor tissue and blood will be obtained from patients diagnosed with
primary uveal melanoma. Patients with a high risk of developing metastases will
be asked to give blood every 6 months (for analysis of biomarkers of
metastases). Metastatic tissue will be obtained (by biopsy or resection) from
patients suspected of or diagnosed with metastases.
Study burden and risks
The analyses in primary UM will be done on tumor tissue that is obtained by
enucleation or biopsy and which remained after diagnostic or prognostic
examination. This involves no additional burden to the patient. Patients with
metastases will be asked for a biopsy for research purposes, besides a biopsy
for diagnostic purposes. This is associated mainly with small risks of pain,
bleeding, local infection.
Peripheral blood will be obtained by venipuncture. There are minimal risks
associated with venipuncture. Participating in this study may be beneficial to
patients who will be followed every six months to give blood, as frequent
contact with physicians may lead to early identification of emerging
metastases. The molecular and cellular analyses, in vitro and in vivo, will not
have direct benefits for the involved patients. The outcomes of this study may
contribute to the future treatment of UM patients.
Albinusdreef 2
Leiden 2333 ZA
NL
Albinusdreef 2
Leiden 2333 ZA
NL
Listed location countries
Age
Inclusion criteria
I-1. Patients must be *18 years of age.
I-3. Patients with either primary UM completing I-4 to I-6 inclusion criteria or with lesions highly suspected of metastases from uveal melanoma and completing I-7 to I-10 inclusion criteria.
I-4. Patients presenting an untreated primary UM diagnosed by local investigator and at a high risk of developing metastatic disease.
I-5. Patients undergoing a fine-needle biopsy aspiration for diagnosis procedure or an enucleation for therapeutic procedure in the setting of its care.
I-6. Tumour tissue should be obtained before any local radiation therapy or systemic treatment.
I-7. Patients presenting lesions highly suspected of metastases from uveal melanoma. Histological confirmation of uveal melanoma metastasis is mandatory and may be done by a local pathologist after inclusion in the study. If the suspected lesions are not uveal melanoma metastases after histological analysis the patient will not be eligible for follow-up analysis.
I-8. Patients undergoing a diagnostic procedure for histological confirmation of metastasis (for instance percutaneous fine needle biopsy, partial hepatectomy etc.) in the setting of routine care. Patients considered by their clinicians, because of any medical condition, at high-risk of procedure complication linked to study sampling should not be included.
I-9. Tumor tissue should be obtained before any systemic treatment for metastatic disease.
I-10. Metastatic patients will be included even if they have had previous surgeries for metastatic UM.
Exclusion criteria
E-1. Patients presenting a melanoma arising from another tissue than choroid (e.g. conjunctiva, skin, mucosa etc.).
E-2. Patients with other malignancy within the last 5 years except: adequately treated non-melanoma skin cancer, curatively treated in situ cancer of the cervix, ductal carcinoma in situ. Patients with a history of localized malignancy diagnosed over 5 years ago may be eligible provided they completed their adjuvant systemic therapy prior to randomization and that the patient remains free of recurrent or metastatic disease.
E-3. Previous systemic treatment for metastatic UM.
E-4. Patients not consenting to tissue or clinical data collection for research purpose
E-5. Patients known to suffer from HIV, active tuberculosis, active hepatitis C, B or other active viral hepatitis.
Design
Recruitment
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL57166.058.16 |