Observational Study of Real World Effectiveness Data and Safety in Patients Receiving Pazopanib With Advanced or Metastatic Renal Cell Carcinoma (PRINCIPAL)

July 14, 2020 updated by: Novartis Pharmaceuticals

PRINCIPAL: A Prospective Observational Study of Real World Treatment Patterns and Treatment Outcomes in Patients With Advanced or Metastatic Renal Cell Carcinoma Receiving Pazopanib

This is a global, multi-centre, long-term, prospective, observational study to evaluate treatment patterns and clinical outcomes in patients with advanced or metastatic RCC treated for the first time with pazopanib. The study is designed to enroll approximately 700-1000 patients in over the course of an enrollment period of approximately 18 months.There are no protocol-mandated visits or procedures associated with the study. Each patient is expected to participate for a maximum of 30 months or until premature discontinuation (i.e., due to death, withdrawal of consent, lost to follow-up or study termination).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a global, multi-centre, long-term, prospective, observational study to evaluate treatment patterns and clinical outcomes in patients with advanced or metastatic RCC treated for the first time with pazopanib. The study is designed to enroll approximately 700-1000 patients in over the course of an enrollment period of approximately 18 months. Sites will be contacted and qualified by the estimated number of advanced or metastatic RCC patients available for enrollment annually. To the extent possible, consecutive patients meeting inclusion/exclusion criteria will be enrolled. Sites will be required to maintain a patient enrolment log of eligible patients at their treatment centres. This log will document how patients came to be included or excluded from the study, in order to assess the representativeness of the study population. The overall number of patients and sites may be adjusted during the study to meet enrollment goals, if needed. Eligible patients will be enrolled by medical oncologists and potentially by urologists experienced in the management of patients with RCC, if consistent with local practice. There are no protocol-mandated visits or procedures associated with the study. Each patient is expected to participate for a maximum of 30 months or until premature discontinuation (i.e., due to death, withdrawal of consent, lost to follow-up or study termination). Follow-up information will be collected approximately every 3 months (a window of ± 4 weeks around the date of the suggested data collection will be allowed). If the patient is not seen for a regularly scheduled visit at that time, the site may contact the patient by telephone to solicit information regarding the events of interest and to limit loss to follow up. It is anticipated that frequency of patient assessment and imaging will differ according to local standard practice; therefore the quarterly data collection time points are intended to collect all assessments (with the date of assessment) since the previous visit date.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
662

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Cordoba, Argentina, X5004FHP
        • Novartis Investigative Site
      • San Miguel de Tucuman, Argentina, T4000IAK
        • Novartis Investigative Site
      • Santa Fe, Argentina, 3000
        • Novartis Investigative Site
    • Buenos Aires
      • Berazategui, Buenos Aires, Argentina, B1880BBF
        • Novartis Investigative Site
    • Córdova
      • Cordoba, Córdova, Argentina, X5006HBF
        • Novartis Investigative Site
    • Santa Fe
      • Rosario, Santa Fe, Argentina, S2000KZE
        • Novartis Investigative Site
  • Austria
      • Hall in Tirol, Austria, 6060
        • Novartis Investigative Site
      • Innsbruck, Austria, 6020
        • Novartis Investigative Site
      • Leoben, Austria, 8700
        • Novartis Investigative Site
      • Linz, Austria, 4021
        • Novartis Investigative Site
      • Salzburg, Austria, 5020
        • Novartis Investigative Site
      • St.Veit/Glan, Austria, 9300
        • Novartis Investigative Site
      • Voecklabruck, Austria, 4840
        • Novartis Investigative Site
      • Wien, Austria, 1090
        • Novartis Investigative Site
      • Wien, Austria, 1220
        • Novartis Investigative Site
  • Belgium
      • Antwerpen, Belgium, 2020
        • Novartis Investigative Site
      • Arlon, Belgium, 6700
        • Novartis Investigative Site
      • Bonheiden, Belgium, 2820
        • Novartis Investigative Site
      • Bouge, Belgium, 5004
        • Novartis Investigative Site
      • Brasschaat, Belgium, 2930
        • Novartis Investigative Site
      • Edegem, Belgium, 2650
        • Novartis Investigative Site
      • Haine Saint Paul, Belgium, 7100
        • Novartis Investigative Site
      • Liege, Belgium, 4000
        • Novartis Investigative Site
      • Oostende, Belgium, 8400
        • Novartis Investigative Site
      • Ottignies, Belgium, 1340
        • Novartis Investigative Site
      • Sint-Niklaas, Belgium, 9100
        • Novartis Investigative Site
      • Verviers, Belgium, 4800
        • Novartis Investigative Site
  • Colombia
      • Bucaramanga, Colombia
        • Novartis Investigative Site
      • Medellin, Colombia
        • Novartis Investigative Site
      • Monteria, Colombia
        • Novartis Investigative Site
  • Estonia
      • Tallinn, Estonia, 13419
        • Novartis Investigative Site
      • Tallinn, Estonia, 10138
        • Novartis Investigative Site
      • Tartu, Estonia, 51014
        • Novartis Investigative Site
  • Finland
      • Helsinki, Finland, 00029
        • Novartis Investigative Site
  • Germany
    • Baden-Wuerttemberg
      • Kirchheim, Baden-Wuerttemberg, Germany, 73230
        • Novartis Investigative Site
    • Bayern
      • Aschaffenburg, Bayern, Germany, 63739
        • Novartis Investigative Site
      • Erlangen, Bayern, Germany, 91054
        • Novartis Investigative Site
      • Hof, Bayern, Germany, 95028
        • Novartis Investigative Site
      • Landshut, Bayern, Germany, 84028
        • Novartis Investigative Site
    • Hessen
      • Frankfurt, Hessen, Germany, 60431
        • Novartis Investigative Site
      • Marburg, Hessen, Germany, 35043
        • Novartis Investigative Site
    • Mecklenburg-Vorpommern
      • Neubrandenburg, Mecklenburg-Vorpommern, Germany, 17036
        • Novartis Investigative Site
      • Rostock, Mecklenburg-Vorpommern, Germany, 18107
        • Novartis Investigative Site
    • Niedersachsen
      • Lehrte, Niedersachsen, Germany, 31275
        • Novartis Investigative Site
    • Nordrhein-Westfalen
      • Muenster, Nordrhein-Westfalen, Germany, 48149
        • Novartis Investigative Site
      • Velbert, Nordrhein-Westfalen, Germany, 42551
        • Novartis Investigative Site
    • Saarland
      • Homburg, Saarland, Germany, 66421
        • Novartis Investigative Site
    • Sachsen
      • Chemnitz, Sachsen, Germany, 09130
        • Novartis Investigative Site
      • Markkleeberg, Sachsen, Germany, 04416
        • Novartis Investigative Site
    • Sachsen-Anhalt
      • Magdeburg, Sachsen-Anhalt, Germany, 39104
        • Novartis Investigative Site
    • Schleswig-Holstein
      • Kiel, Schleswig-Holstein, Germany, 24105
        • Novartis Investigative Site
  • Greece
      • Athens, Greece, 115 28
        • Novartis Investigative Site
      • Athens, Greece, 11522
        • Novartis Investigative Site
      • Patra, Greece, 26504
        • Novartis Investigative Site
      • Thessaloniki, Greece, 564 29
        • Novartis Investigative Site
      • Thessaloniki, Greece
        • Novartis Investigative Site
  • Hungary
      • Budapest, Hungary, 1082
        • Novartis Investigative Site
      • Budapest, Hungary, 1145
        • Novartis Investigative Site
      • Budapest, Hungary, 1097
        • Novartis Investigative Site
      • Budapest, Hungary, 1122
        • Novartis Investigative Site
      • Debrecen, Hungary, H-4032
        • Novartis Investigative Site
      • Pecs, Hungary, 7624
        • Novartis Investigative Site
      • Szeged, Hungary, 6720
        • Novartis Investigative Site
      • Szombathely, Hungary, 9700
        • Novartis Investigative Site
      • Veszprem, Hungary, 8200
        • Novartis Investigative Site
  • Israel
      • Haifa, Israel, 31096
        • Novartis Investigative Site
      • Haifa, Israel, 31048
        • Novartis Investigative Site
      • Jerusalem, Israel, 91120
        • Novartis Investigative Site
      • Nahariya, Israel, 22100
        • Novartis Investigative Site
      • Tel Aviv, Israel, 64239
        • Novartis Investigative Site
  • Italy
    • Campania
      • Napoli, Campania, Italy, 80131
        • Novartis Investigative Site
    • Emilia-Romagna
      • Modena, Emilia-Romagna, Italy, 41100
        • Novartis Investigative Site
    • Lazio
      • Roma, Lazio, Italy, 00168
        • Novartis Investigative Site
      • Roma, Lazio, Italy, 00144
        • Novartis Investigative Site
      • Roma, Lazio, Italy, 00152
        • Novartis Investigative Site
    • Lombardia
      • Cremona, Lombardia, Italy, 26100
        • Novartis Investigative Site
      • Milano, Lombardia, Italy, 20133
        • Novartis Investigative Site
      • Pavia, Lombardia, Italy, 27100
        • Novartis Investigative Site
  • Lebanon
      • Ashrafieh, Lebanon, 166484
        • Novartis Investigative Site
  • Pakistan
      • Karachi, Pakistan, 74800
        • Novartis Investigative Site
  • Spain
      • Albacete, Spain, 02006
        • Novartis Investigative Site
      • Badajoz, Spain, 06080
        • Novartis Investigative Site
      • Barcelona, Spain, 08035
        • Novartis Investigative Site
      • Barcelona, Spain, 08036
        • Novartis Investigative Site
      • Barcelona, Spain, 08041
        • Novartis Investigative Site
      • Barcelona, Spain, 08003
        • Novartis Investigative Site
      • Burgos, Spain, 09006
        • Novartis Investigative Site
      • Castellon, Spain, 12002
        • Novartis Investigative Site
      • Don Benito/Badajoz, Spain, 06400
        • Novartis Investigative Site
      • Guadalajara, Spain, 19002
        • Novartis Investigative Site
      • La Coruna, Spain, 15006
        • Novartis Investigative Site
      • La Laguna (Santa Cruz De Tenerife), Spain, 38320
        • Novartis Investigative Site
      • Leon, Spain, 24071
        • Novartis Investigative Site
      • Lleida, Spain, 25198
        • Novartis Investigative Site
      • Lugo, Spain, 27003
        • Novartis Investigative Site
      • Manresa (Barcelona), Spain, 08243
        • Novartis Investigative Site
      • Ourense, Spain, 32005
        • Novartis Investigative Site
      • Pamplona, Spain, 31008
        • Novartis Investigative Site
      • Sabadell (Barcelona), Spain, 08208
        • Novartis Investigative Site
      • Salamanca, Spain, 37007
        • Novartis Investigative Site
      • San Sebastian, Spain, 20014
        • Novartis Investigative Site
      • Santa Cruz de Tenerife, Spain, 38010
        • Novartis Investigative Site
      • Santiago de Compostela, Spain, 15706
        • Novartis Investigative Site
      • Soria, Spain, 42002
        • Novartis Investigative Site
      • Valencia, Spain, 46009
        • Novartis Investigative Site
      • Valladolid, Spain, 47005
        • Novartis Investigative Site
      • Vigo ( Pontevedra), Spain, 36204
        • Novartis Investigative Site
      • Zaragoza, Spain, 50009
        • Novartis Investigative Site
  • Taiwan
      • Kaohsiung, Taiwan, 807
        • Novartis Investigative Site
      • Kaohsiung, Taiwan, 813
        • Novartis Investigative Site
      • Taichung, Taiwan, 40402
        • Novartis Investigative Site
      • Taipei, Taiwan
        • Novartis Investigative Site
      • Taipei, Taiwan, 104
        • Novartis Investigative Site
      • Taoyuan Hsien, Taiwan, ROC
        • Novartis Investigative Site
  • Turkey
      • Ankara, Turkey, 06500
        • Novartis Investigative Site
      • Ankara, Turkey
        • Novartis Investigative Site
      • Antalya, Turkey, 07059
        • Novartis Investigative Site
      • Antalya, Turkey
        • Novartis Investigative Site
      • Istanbul, Turkey, 34390
        • Novartis Investigative Site
      • Istanbul, Turkey, 34365
        • Novartis Investigative Site
      • Izmir, Turkey
        • Novartis Investigative Site
      • Kayseri, Turkey, 38039
        • Novartis Investigative Site
      • Malatya, Turkey
        • Novartis Investigative Site
      • Samsun, Turkey, 55139
        • Novartis Investigative Site
  • United Kingdom
      • Birmingham, United Kingdom, B9 5SS
        • Novartis Investigative Site
      • Leicester, United Kingdom, LE1 5WW
        • Novartis Investigative Site
      • Manchester, United Kingdom, M20 4BX
        • Novartis Investigative Site
      • Shrewsbury, United Kingdom, SY3 8XQ
        • Novartis Investigative Site
    • Middlesex
      • Northwood, Middlesex, United Kingdom, HA6 2RN
        • Novartis Investigative Site
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85016
        • Novartis Investigative Site
    • California
      • Orange, California, United States, 92868
        • Novartis Investigative Site
    • Florida
      • Jacksonville, Florida, United States, 32256
        • Novartis Investigative Site
    • Kentucky
      • Louisville, Kentucky, United States, 40207
        • Novartis Investigative Site
    • Louisiana
      • Shreveport, Louisiana, United States, 71101
        • Novartis Investigative Site
    • Mississippi
      • Jackson, Mississippi, United States, 39202
        • Novartis Investigative Site
    • Nebraska
      • Lincoln, Nebraska, United States, 68510
        • Novartis Investigative Site
    • Nevada
      • Henderson, Nevada, United States, 89052
        • Novartis Investigative Site
    • New York
      • Bronx, New York, United States, 10467
        • Novartis Investigative Site
    • South Carolina
      • Charleston, South Carolina, United States, 29414
        • Novartis Investigative Site
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57105
        • Novartis Investigative Site
    • Texas
      • Austin, Texas, United States, 78705
        • Novartis Investigative Site
      • Dallas, Texas, United States, 75246
        • Novartis Investigative Site
      • Fort Worth, Texas, United States, 76104
        • Novartis Investigative Site
      • Houston, Texas, United States, 77024
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

This observational studies plans to recruit from cliinics that are prescribing pazopanib to patients as part local standard of practice.

Description

Inclusion Criteria:

  • Patients eligible for enrolment in the study must meet all of the following criteria:

    • Age ≥ 18 years at enrollment
    • Documented diagnosis of advanced and/or metastatic clear cell or predominantly clear cell RCC
    • Clinical decision made to initiate treatment with pazopanib prior to enrollment in the study, but within 30 days of enrollment
    • Willing and able to provide written informed consent

Exclusion Criteria:

  • Patients meeting any of the following criteria must not be enrolled in the study:

    • Patients currently participating in any interventional clinical trials in which treatment regimen and/or monitoring is dictated by a protocol
    • Previous exposure to an investigational or licensed multi-kinase inhibitor or an anti- VEGF angiogenesis inhibitor for advanced or metastatic disease
    • Life expectancy < 12 weeks

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Pazopanib
Prospective Observational study collecting real world data on Pazopanib in patients with advanced or metastatic Renal Cell Carcinoma. Study is considered non-interventional, no drug will be provided. No study visits or procedures are mandated per protocol.
Drug: Pazopanib
Prospective Observational study collecting real world data on Pazopanib in patients with advanced or metastatic Renal Cell Carcinoma. Study is considered non-interventional, no drug will be provided. No study visits or procedures are mandated per protocol.
Other Names:
  • Votrient

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Efficacy
Time Frame: Approximately 30 months
To evaluate overall survival (OS), progression-free survival (PFS) and the overall response rate (ORR) in patients treated with pazopanib
Approximately 30 months
Relative Dose Intensity(RDI)
Time Frame: Approximately 30 months
To characterize the relative dose intensity (RDI) and its observed effect on treatment outcomes
Approximately 30 months
Characterise the RCC patient population treated
Time Frame: Approximately 30 months
To characterise the RCC patient population treated with pazopanib (e.g., by demographics, disease characteristics, previous RCC treatment history) in comparison to a selected clinical trial population
Approximately 30 months
Evaluate the change in health-related quality of life (HRQoL)
Time Frame: Approximately 30 months from baseline
To evaluate the change in health-related quality of life (HRQoL) relative to baseline in patients treated with pazopanib
Approximately 30 months from baseline
Evaluate Safety
Time Frame: From first treatment with pazopanib till 30 days after last dose of pazopanib treatment
To evaluate the frequency of serious adverse events(SAEs) and adverse events of special interest (AESIs) in patients treated with pazopanib. Endpoint: Any adverse event that results in a pazopanib dose modification or discontinuation. Evidence of liver toxicity (e.g., increased ALT and/or AST, liver failure). New onset or worsened hypertension. Cardiac dysfunction (e.g., decreased left ventricular function, congestive heart failure). Thyroid dysfunction.
From first treatment with pazopanib till 30 days after last dose of pazopanib treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Evaluate efficacy and safety comparable to VEG105192
Time Frame: Approximately 30 months
To evaluate clinical effectiveness, safety and RDI in those patients with comparable baseline characteristics to those included in the Phase III clinical trial [VEG105192]. Endpoints: Same as primary effectiveness, safety and RDI objectives
Approximately 30 months
Evaluate efficacy, safety, RDI, and HRQoL
Time Frame: Approximately 30 months
To evaluate clinical effectiveness, safety, RDI and HRQoL in relevant subgroups treated with pazopanib
Approximately 30 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 19, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 3, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 3, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 23, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 23, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 25, 2012

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 15, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 14, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 115232
  • CPZP034A2401 (Other Identifier: Novartis)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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