Melanoma;NCT01281722
Role of SLURP-1 in Melanoma and Melanoma Stem Cells
An observational study of Melanoma;, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Melanoma is the most aggressive skin cancer, with a propensity to metastasize, and is resistant to most of the current therapeutic regimens. Incidence rate of melanoma in patients with MDM (Mal De Maleda, with SLURP-1 mutation) is much higher than normal counterpart. Read more about this study
- Who is it for?
- Ages 20 to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- Melanoma;
- How many people
- 150 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2011to Jul 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 20 to 95 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: case and control study of melanoma disease
Who may be able to join
- Clinical diagnosis of melanoma Disease by NTU hospital(group of cases)
- healthy adults(groups of control)
Who cannot join
- two groups whose age are younger than 20 or older tha 95 years old
- Clinical diagnosis of non-melanoma Disease by NTU hospital(group of cases)
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Department of Dermatology, National Taiwan University Hospital.
Taipei, 100
Shiou-Hwa Jee, M.D., Ph.D., 886-9-72651116, shiouhwa@gmail.com; shiouhwa@ntu.edu.tw
Jung-Ting Kao, M.D.
About this study
Melanoma is the most aggressive skin cancer, with a propensity to metastasize, and is resistant to most of the current therapeutic regimens. Incidence rate of melanoma in patients with MDM (Mal De Maleda, with SLURP-1 mutation) is much higher than normal counterpart. SLURP-1 (lymphocyte antigen 6/urokinase-type plasminogen activator receptor related protein-1) is an allosteric agonist to the nicotinic acetylcholine receptor (nAchR) and it regulates epidermal homeostasis and T-cell function. The preliminary results of comparing human peripheral blood mononuclear cells (PBMCs) from 4 affected and 15 unaffected members from the family with MDM revealed that T-cell activation was impaired in PBMCs with the heterozygous and homozygous SLURP-1 G86R mutation. (2 of affected members developed melanoma.) Since there is currently no effective treatment for metastatic melanoma, identifying novel molecular mechanisms may lead to development of new treatments for metastatic melanomas.
Previous study showed that melanoma stem cells (MSCs) are crucial in melanoma pathogenesis: 1.Melanoma contains ABCB5, CD133 and ABCG2 positive cells had enhanced tumorigenic potential. 2.Higher frequencies of cells capable of initiating melanoma xenografts when using IL2Rγ-/- NOD SCID mice. These data confirmed the interaction between T cells and MSCs.
Read more
In this project, we will investigate the roles of SLURP-1 in melanoma and MSCs. Investigating and verifying the interaction between T-cells from patients with MDM and melanoma cells to confirm the SLURP-1 function of tumorigenesis in xenotransplant mice (IL2Rγ-/- NOD SCID) model. To reveal the role of SLURP-1 silencing in melanoma cell lines by using not only A2058 , A375 and MeWo mwlanima cell lines but also ABCB5+ melanoma cells and ABCB5- melanoma cells through the tumorigenesis, apoptosis,angiogenesis, proliferation, melanosphere formation assays.
The aim of this project is to investigate the roles and molecular mechanisms of SLURP-1 in melanoma carcinogenesis, which may improve the development of novel treatments for melanoma.
Read the detailed description
Cutaneous melanoma is an aggressive neoplasm refractory to traditional therapies, especially at the metastatic stage. Furthermore, its incidence is continuously increasing during the last decade (1). Melanomas develop through a multistep process that from normal melanocytes proceeds to nevi and to radial and vertical growth phase tumors (2). During this process, melanomas are characterized by certain well-defined genetic alterations as well as frequent chromosomal aberrations associated with tumor progression (3). However, the molecular mechanisms involved in the carcinogenesis and progression of melanoma are complex and not entirely clear (4). Because of the intractability of metastatic melanomas with only 14% of the patients survive for 5 years and no effective treatments (2), understanding the underlying molecular mechanisms involved in melanoma and identifying molecular markers may lead to improvements in therapeutic approaches for metastatic melanomas.
Mal de Meleda (MDM; OMIM 248300) is a rare autosomal recessive disorder characterized by erythema and hyperkeratosis of the palms and soles, extending to the dorsal aspects of the hands and feet (known as transgrediens), and perioral erythema and psoriasiform plaques on the elbows and knees. (5-7) Homozygous mutations of the SLURP1 gene (previously known as ARS component B) encoding lymphocyte antigen 6/urokinase-type plasminogen activator receptor related protein-1 (SLURP-1) have been identified as the cause of MDM. (8-10) Mutations of the SLURP1 gene affect the expression, integrity and stability of SLURP-1 on the upper layer of the epidermis and in cultured mature keratinocytes. (11) Other studies also demonstrated that SLURP-1 acts as a positive allosteric ligand for 7-nAchR in keratinocytes, eliciting proapoptotic activity and differentiation. (12,13) As well as in epidermis and keratinocytes, the expression of SLURP-1 has been found in T cells, B cells, dendritic cells and macrophages. (14-15) Malignant melanoma (MM) has been reported to be the predominant cutaneous malignancy occurring in the hyperkeratotic area in patients with MDM. (16) The incidence of MM in MDM is significantly higher than in the general population.(17) At least six cases of MM have been reported in patients with MDM;27-29 two of the reported cases were siblings. (18) The possible explanations of the higher incidence of MM in patients with MDM include: (i) lack of proapoptotic effect of SLURP-1; (ii) defective T-cell activation and tumour monitoring; or (iii) prolonged inflammation in hyperkeratotic skin.
The previous study showed that peripheral blood mononuclear cells (PBMCs) with the heterozygous and homozygous SLURP-1 G86R mutation had defective T-cell activation. This was restored by the addition of 0•5 μg mL-1 recombinant human SLURP-1 protein. (19) Previous study showed that a putative monoclonal antibody that recognized ABCB5 was used to isolate melanoma stem cells (MSCs). (20) In this study, the investigators will investigate the roles of SLURP-1 in melanoma cells (including MSC) and also its interaction between melanoma cells and T-cells.
Aims：
- To evaluate the significance and correlation of SLURP-1 expression in melanoma cells and melanoma metastasis in human tissues and mouse metastasis models.
- To assess the function of the SLURP-1 protein in melanoma cells and melanoma stem cells.
- To investigate the interaction between T-cells with SLURP-1 mutation and melanoma cells / MSCs.
- Confirm the biological effects of SLURP-1 on melanoma cells / MSCs.
- To investigate the relationship between SLURP-1 overexpression and melanoma cancer biology.
References
- Gray-Schopfer V, Wellbrock C, Marais R. Melanoma biology and new target therapy. Nature 2007; 445: 851-7.
- Miller AJ, Mihm MC. Melanoma. N Engl J Med 2006; 355: 51-65.
- Jonsson G, et al. Genomic profiling of malignant melanoma using tiling-resolution array CGH. Oncogene 2007; 6: 4738-48.
- Bemis LT, Chen R, Amato CM et al. MicroRNA-137 targets microphthalmia-associated transcription factor in melanoma cell lines. Cancer Res 2008; 68: 1362-8.
- Lucker GP, Van De Kerkhof PC, Steijlen PM. The hereditary palmoplantar keratoses: an updated review and classification. Br J Dermatol 1994; 131:1-14.
- Bergman R, Bitterman-Deutsch O, Fartasch M et al. Mal de Meleda keratoderma with pseudoainhum. Br J Dermatol 1993; 128:207-12.
- Jee SH, Lee YY, Wu YC et al. Report of a family with mal de Meleda in Taiwan: a clinical, histopathological and immunological study. Dermatologica 1985; 171:30-7.
- Fischer J, Bouadjar B, Heilig R et al. Mutations in the gene encoding SLURP-1 in Mal de Meleda. Hum Mol Genet 2001; 10:875-80.
- Ward KM, Yerebakan O, Yilmaz E et al. Identification of recurrent mutations in the ARS (component B) gene encoding SLURP-1 in two families with mal de Meleda. J Invest Dermatol 2003; 120:96-8.
- Mastrangeli R, Donini S, Kelton CA et al. ARS component B: structural characterization, tissue expression and regulation of the gene and protein (SLURP-1) associated with mal de Meleda. Eur J Dermatol 2003; 13:560-70.
- Favre B, Plantard L, Aeschbach L et al. SLURP1 is a late marker of epidermal differentiation and is absent in mal de Meleda. J Invest Dermatol 2007; 127:301-8.
- Grando SA. Basic and clinical aspects of non-neuronal acetylcholine: biological and clinical significance of non-canonical ligands of epithelial nicotinic acetylcholine receptors. J Pharmacol Sci 2008; 106:174-9.
- Arredondo J, Chernyavsky AI, Webber RJ et al. Biological effects of SLURP-1 on human keratinocytes. J Invest Dermatol 2005; 125:1236-41.
- Moriwaki Y, Yoshikawa K, Fukuda H et al. Immune system expression of SLURP-1 and SLURP-2, two endogenous nicotinic acetylcholine receptor ligands. Life Sci 2007; 80:2365-8.
- Kawashima K, Yoshikawa K, Fujii YX et al. Expression and function of genes encoding cholinergic components in murine immune cells. Life Sci 2007; 80:2314-19.
- Nakajima K, Nakano H, Takiyoshi N et al. Papillon-Lefèvre syndrome and malignant melanoma. A high incidence of melanoma development in Japanese palmoplantar keratoderma patients. Dermatology 2008; 217:58-62.
- Sartore L, Bordignon M, Bassetto F et al. Melanoma in skin affected with keratoderma palmoplantaris hereditaria (mal de Meleda): treatment with excision and grafting. J Am Acad Dermatol 2009; 61:161-3.
- Mozzillo N, Nunziata CA, Caraco C et al. Malignant melanoma developing in an area of hereditary palmoplantar keratoderma (mal de Meleda). J Surg Oncol 2003; 84:229-33.
- Tjiu JW, Lin PJ, Wu WH et al. SLURP1 mutation-impaired T-cell activation in a family with mal de Meleda. Br J Dermatol. 2010 Sep 21
- Schatton T, Murphy GF, Frank NY et al. Identification of cells initiating human melanomas. Nature. 2008 Jan 17;451(7176):345-9
- Conditions
- Melanoma;
- Keywords
- healthy adults, melanoma
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| healthy adults | healthy adults with the age among 20 to 95 years old | |
| melanoma cases | the people who are diagnosed melanoma in NTU hospital |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionJul 2014 (estimated)
- Study completionJul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Melanoma;Studies 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-control
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Shiou-Hwa Jee, M.D., Ph.D., Study chair, Department of Dermatology, National Taiwan University Hospital.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01281722
- Sponsor's protocol ID
- 201012044RB
- Status last verified
- Jan 2011
- First submitted
- 20 Jan 2011
- Last updated
- 24 Jan 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of SLURP-1 in Melanoma and Melanoma Stem Cells
- ClinicalTrials.gov ID
- NCT01281722
- Acronym / sponsor ID
- 201012044RB
- Conditions
- Melanoma;
- Keywords
- healthy adults, melanoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Jul 2014 (estimated)
- Study completion
- Jul 2019 (estimated)
- First posted
- 24 Jan 2011 (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.
Melanoma is the most aggressive skin cancer, with a propensity to metastasize, and is resistant to most of the current therapeutic regimens. Incidence rate of melanoma in patients with MDM (Mal De Maleda, with SLURP-1 mutation) is much higher than normal counterpart. SLURP-1 (lymphocyte antigen 6/urokinase-type plasminogen activator receptor related protein-1) is an allosteric agonist to the nicotinic acetylcholine receptor (nAchR) and it regulates epidermal homeostasis and T-cell function. The preliminary results of comparing human peripheral blood mononuclear cells (PBMCs) from 4 affected and 15 unaffected members from the family with MDM revealed that T-cell activation was impaired in PBMCs with the heterozygous and homozygous SLURP-1 G86R mutation. (2 of affected members developed melanoma.) Since there is currently no effective treatment for metastatic melanoma, identifying novel molecular mechanisms may lead to development of new treatments for metastatic melanomas.
Previous study showed that melanoma stem cells (MSCs) are crucial in melanoma pathogenesis: 1.Melanoma contains ABCB5, CD133 and ABCG2 positive cells had enhanced tumorigenic potential. 2.Higher frequencies of cells capable of initiating melanoma xenografts when using IL2Rγ-/- NOD SCID mice. These data confirmed the interaction between T cells and MSCs.
In this project, we will investigate the roles of SLURP-1 in melanoma and MSCs. Investigating and verifying the interaction between T-cells from patients with MDM and melanoma cells to confirm the SLURP-1 function of tumorigenesis in xenotransplant mice (IL2Rγ-/- NOD SCID) model. To reveal the role of SLURP-1 silencing in melanoma cell lines by using not only A2058 , A375 and MeWo mwlanima cell lines but also ABCB5+ melanoma cells and ABCB5- melanoma cells through the tumorigenesis, apoptosis,angiogenesis, proliferation, melanosphere formation assays.
The aim of this project is to investigate the roles and molecular mechanisms of SLURP-1 in melanoma carcinogenesis, which may improve the development of novel treatments for melanoma.
Detailed description
Cutaneous melanoma is an aggressive neoplasm refractory to traditional therapies, especially at the metastatic stage. Furthermore, its incidence is continuously increasing during the last decade (1). Melanomas develop through a multistep process that from normal melanocytes proceeds to nevi and to radial and vertical growth phase tumors (2). During this process, melanomas are characterized by certain well-defined genetic alterations as well as frequent chromosomal aberrations associated with tumor progression (3). However, the molecular mechanisms involved in the carcinogenesis and progression of melanoma are complex and not entirely clear (4). Because of the intractability of metastatic melanomas with only 14% of the patients survive for 5 years and no effective treatments (2), understanding the underlying molecular mechanisms involved in melanoma and identifying molecular markers may lead to improvements in therapeutic approaches for metastatic melanomas.
Mal de Meleda (MDM; OMIM 248300) is a rare autosomal recessive disorder characterized by erythema and hyperkeratosis of the palms and soles, extending to the dorsal aspects of the hands and feet (known as transgrediens), and perioral erythema and psoriasiform plaques on the elbows and knees. (5-7) Homozygous mutations of the SLURP1 gene (previously known as ARS component B) encoding lymphocyte antigen 6/urokinase-type plasminogen activator receptor related protein-1 (SLURP-1) have been identified as the cause of MDM. (8-10) Mutations of the SLURP1 gene affect the expression, integrity and stability of SLURP-1 on the upper layer of the epidermis and in cultured mature keratinocytes. (11) Other studies also demonstrated that SLURP-1 acts as a positive allosteric ligand for 7-nAchR in keratinocytes, eliciting proapoptotic activity and differentiation. (12,13) As well as in epidermis and keratinocytes, the expression of SLURP-1 has been found in T cells, B cells, dendritic cells and macrophages. (14-15) Malignant melanoma (MM) has been reported to be the predominant cutaneous malignancy occurring in the hyperkeratotic area in patients with MDM. (16) The incidence of MM in MDM is significantly higher than in the general population.(17) At least six cases of MM have been reported in patients with MDM;27-29 two of the reported cases were siblings. (18) The possible explanations of the higher incidence of MM in patients with MDM include: (i) lack of proapoptotic effect of SLURP-1; (ii) defective T-cell activation and tumour monitoring; or (iii) prolonged inflammation in hyperkeratotic skin.
The previous study showed that peripheral blood mononuclear cells (PBMCs) with the heterozygous and homozygous SLURP-1 G86R mutation had defective T-cell activation. This was restored by the addition of 0•5 μg mL-1 recombinant human SLURP-1 protein. (19) Previous study showed that a putative monoclonal antibody that recognized ABCB5 was used to isolate melanoma stem cells (MSCs). (20) In this study, the investigators will investigate the roles of SLURP-1 in melanoma cells (including MSC) and also its interaction between melanoma cells and T-cells.
Aims：
- To evaluate the significance and correlation of SLURP-1 expression in melanoma cells and melanoma metastasis in human tissues and mouse metastasis models.
- To assess the function of the SLURP-1 protein in melanoma cells and melanoma stem cells.
- To investigate the interaction between T-cells with SLURP-1 mutation and melanoma cells / MSCs.
- Confirm the biological effects of SLURP-1 on melanoma cells / MSCs.
- To investigate the relationship between SLURP-1 overexpression and melanoma cancer biology.
References
- Gray-Schopfer V, Wellbrock C, Marais R. Melanoma biology and new target therapy. Nature 2007; 445: 851-7.
- Miller AJ, Mihm MC. Melanoma. N Engl J Med 2006; 355: 51-65.
- Jonsson G, et al. Genomic profiling of malignant melanoma using tiling-resolution array CGH. Oncogene 2007; 6: 4738-48.
- Bemis LT, Chen R, Amato CM et al. MicroRNA-137 targets microphthalmia-associated transcription factor in melanoma cell lines. Cancer Res 2008; 68: 1362-8.
- Lucker GP, Van De Kerkhof PC, Steijlen PM. The hereditary palmoplantar keratoses: an updated review and classification. Br J Dermatol 1994; 131:1-14.
- Bergman R, Bitterman-Deutsch O, Fartasch M et al. Mal de Meleda keratoderma with pseudoainhum. Br J Dermatol 1993; 128:207-12.
- Jee SH, Lee YY, Wu YC et al. Report of a family with mal de Meleda in Taiwan: a clinical, histopathological and immunological study. Dermatologica 1985; 171:30-7.
- Fischer J, Bouadjar B, Heilig R et al. Mutations in the gene encoding SLURP-1 in Mal de Meleda. Hum Mol Genet 2001; 10:875-80.
- Ward KM, Yerebakan O, Yilmaz E et al. Identification of recurrent mutations in the ARS (component B) gene encoding SLURP-1 in two families with mal de Meleda. J Invest Dermatol 2003; 120:96-8.
- Mastrangeli R, Donini S, Kelton CA et al. ARS component B: structural characterization, tissue expression and regulation of the gene and protein (SLURP-1) associated with mal de Meleda. Eur J Dermatol 2003; 13:560-70.
- Favre B, Plantard L, Aeschbach L et al. SLURP1 is a late marker of epidermal differentiation and is absent in mal de Meleda. J Invest Dermatol 2007; 127:301-8.
- Grando SA. Basic and clinical aspects of non-neuronal acetylcholine: biological and clinical significance of non-canonical ligands of epithelial nicotinic acetylcholine receptors. J Pharmacol Sci 2008; 106:174-9.
- Arredondo J, Chernyavsky AI, Webber RJ et al. Biological effects of SLURP-1 on human keratinocytes. J Invest Dermatol 2005; 125:1236-41.
- Moriwaki Y, Yoshikawa K, Fukuda H et al. Immune system expression of SLURP-1 and SLURP-2, two endogenous nicotinic acetylcholine receptor ligands. Life Sci 2007; 80:2365-8.
- Kawashima K, Yoshikawa K, Fujii YX et al. Expression and function of genes encoding cholinergic components in murine immune cells. Life Sci 2007; 80:2314-19.
- Nakajima K, Nakano H, Takiyoshi N et al. Papillon-Lefèvre syndrome and malignant melanoma. A high incidence of melanoma development in Japanese palmoplantar keratoderma patients. Dermatology 2008; 217:58-62.
- Sartore L, Bordignon M, Bassetto F et al. Melanoma in skin affected with keratoderma palmoplantaris hereditaria (mal de Meleda): treatment with excision and grafting. J Am Acad Dermatol 2009; 61:161-3.
- Mozzillo N, Nunziata CA, Caraco C et al. Malignant melanoma developing in an area of hereditary palmoplantar keratoderma (mal de Meleda). J Surg Oncol 2003; 84:229-33.
- Tjiu JW, Lin PJ, Wu WH et al. SLURP1 mutation-impaired T-cell activation in a family with mal de Meleda. Br J Dermatol. 2010 Sep 21
- Schatton T, Murphy GF, Frank NY et al. Identification of cells initiating human melanomas. Nature. 2008 Jan 17;451(7176):345-9
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| healthy adults | – | –healthy adults with the age among 20 to 95 years old |
| melanoma cases | – | –the people who are diagnosed melanoma in NTU hospital |
Who may qualify
- Ages
- 20 to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- case and control study of melanoma disease
Key inclusion criteria (2 listed)
- Clinical diagnosis of melanoma Disease by NTU hospital(group of cases)
- healthy adults(groups of control)
Key exclusion criteria (2 listed)
- two groups whose age are younger than 20 or older tha 95 years old
- Clinical diagnosis of non-melanoma Disease by NTU hospital(group of cases)
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
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2011.
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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.
Shiou-Hwa Jee, M.D., Ph.D. study chair
Department of Dermatology, 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 Melanoma;, 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 2 inclusion and 2 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 24 Jan 2011. 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 Shiou-Hwa Jee, M.D., Ph.D. (886-9-72651116, shiouhwa@gmail.com; shiouhwa@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 24 Jan 2011.