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Recruiting

NCT Number: NCT05217407

Marker Assisted Selective ThErapy in Rare Cancers: Knowledge Database Establishing registrY Asia

This is a registry study that aims to collect patients' data with advanced-stage rare cancer in Asia-Pacific region. Data includes clinical information, details of treatment, prognosis, pathological diagnosis and genetic biomarkers by next-generation sequencing.

The relationship between cancer types and prognosis, the effect of treatments, and the cancer type-specific incidence of genomic alterations will be investigated to discover more specific and effective treatment.

Recruiting

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Key information

Conditions

Rare Malignant Neoplasm

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

National Cancer Center Hospital, Japan, Chuo-ku, Tokyo, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with a histological diagnosis of rare cancer, cancer of unknown primary origin, or cancer of rare tissue subtypes of common cancers. (Defined in protocol.)
  • Patients with Advanced stage cancer.

Exclusion criteria

  • Patients with complications of cognitive impairment.

Treatment and study plan

Genomic sequence

Other

Genomic sequence

Primary outcomes

  1. Overall incidence of any genomic alteration in overall population

    Time frame: 1 year

    Overall incidence of any genomic alteration in overall population

  2. Overall incidence of any genomic alteration in patients with a certain cancer type

    Time frame: 1 year

    Overall incidence of any genomic alteration in patients with a certain cancer type

Secondary outcomes

  1. Incidence of individual genomic alteration in overall population

    Time frame: 1 year

    The incidence of individual genomic alterations in overall population

  2. Incidence of individual genomic alteration in patients with a certain cancer type

    Time frame: 1 year

    The incidence of individual genomic alterations in patients with a certain cancer type

Other outcomes

  1. Biomarker positive proportion in overall population

    Time frame: 1 year

    The proportion of patients positive for certain biomarkers in overall population

  2. Biomarker positive proportion in patients with a certain cancer type

    Time frame: 1 year

    The proportion of patients positive for certain biomarkers in patients with a certain cancer type

  3. Number of somatic variants within exons in overall population

    Time frame: 1 year

    The number of somatic variants and proportion of variants in overall population

  4. Number of somatic variants within exons in patients with a certain cancer type

    Time frame: 1 year

    The number of somatic variants and proportion of variants in patients with a certain cancer type

  5. Response rate in patients treated with biomarker/genomic alteration-based therapy

    Time frame: 1 year

    Response rate in patients treated with biomarker/genomic alteration-based therapy in overall population, in patients with a certain cancer type, in patients who tested positive/negative for a certain biomarker (any cancer type), in patients with/without a certain genomic alteration (any cancer type), in patients who tested positive/negative for a certain biomarker for a certain cancer type, & in patients with/without a certain genomic alteration for a certain cancer type.

  6. Response rate in patients treated with a therapy other than biomarker/genomic alteration-based therapy

    Time frame: 1 year

    Response rate in patients treated with a therapy other than biomarker/genomic alteration-based therapy in overall population, in patients with a certain cancer type, in patients who tested positive/negative for a certain biomarker (any cancer type), in patients with/without a certain genomic alteration (any cancer type), in patients who tested positive/negative for a certain biomarker for a certain cancer type, & in patients with/without a certain genomic alteration for a certain cancer type.

  7. Response rate in patients treated with immune checkpoint inhibitors

    Time frame: 1 year

    Response rate in patients treated with immune checkpoint inhibitors in overall population, in patients with a certain cancer type, in patients who tested positive/negative for a certain biomarker (any cancer type), in patients with/without a certain genomic alteration (any cancer type), in patients who tested positive/negative for a certain biomarker for a certain cancer type, & in patients with/without a certain genomic alteration for a certain cancer type.

  8. Disease control rate in patients treated with biomarker/genomic alteration-based therapy

    Time frame: 1 year

    Disease control rate in patients treated with biomarker/genomic alteration-based therapy in overall population, in patients with a certain cancer type, in patients who tested positive/negative for a certain biomarker (any cancer type), in patients with/without a certain genomic alteration (any cancer type), in patients who tested positive/negative for a certain biomarker for a certain cancer type, & in patients with/without a certain genomic alteration for a certain cancer type.

  9. Disease control rate in patients treated with a therapy other than biomarker/genomic alteration-based therapy

    Time frame: 1 year

    Disease control rate in patients treated with a therapy other than biomarker/genomic alteration-based therapy in overall population, in patients with a certain cancer type, in patients who tested positive/negative for a certain biomarker (any cancer type), in patients with/without a certain genomic alteration (any cancer type), in patients who tested positive/negative for a certain biomarker for a certain cancer type, & in patients with/without a certain genomic alteration for a certain cancer type.

  10. Disease control rate in patients treated with immune checkpoint inhibitors

    Time frame: 1 year

    Disease control rate in patients treated with immune checkpoint inhibitors in overall population, in patients with a certain cancer type, in patients who tested positive/negative for a certain biomarker (any cancer type), in patients with/without a certain genomic alteration (any cancer type), in patients who tested positive/negative for a certain biomarker for a certain cancer type, & in patients with/without a certain genomic alteration for a certain cancer type.

  11. Overall survival

    Time frame: 1 year

    Overall survival in overall population, in patients with a certain cancer type, in patients who tested positive/negative for a certain biomarker (any cancer type), in patients with/without a certain genomic alteration (any cancer type), in patients who tested positive/negative for a certain biomarker for a certain cancer type, & in patients with/without a certain genomic alteration for a certain cancer type.

  12. Progression-free survival

    Time frame: 1 year

    Progression-free survival in overall population, in patients with a certain cancer type, in patients who tested positive/negative for a certain biomarker (any cancer type), in patients with/without a certain genomic alteration (any cancer type), in patients who tested positive/negative for a certain biomarker for a certain cancer type, & in patients with/without a certain genomic alteration for a certain cancer type.

  13. Proportion of patients receiving no treatment with observation-only in real-world clinical practice

    Time frame: 1 year

    Proportion of patients receiving no treatment with observation-only in real-world clinical practice in overall population & in patients with a certain cancer type. Proportion of patients receiving no treatment or observation with best supportive care in real-world clinical practice in overall population & in patients with a certain cancer type.

Study contacts

Contact information is provided by the study sponsor or research team.

Chiharu Mizoguchi, MD

CONTACT

[email protected]

+81-(0)3-3542-2511

Hitomi Okuma, MD, PhD

CONTACT

[email protected]

+81-(0)3-3542-2511

Sponsors and collaborators

Lead sponsor

National Cancer Center, Japan

Other Gov

Registry information

Official study title

A Prospective Clinical Registry Study of Genetic Profiling and Targeted Therapies in Patients With Rare Cancers in ASIA

Acronym: MASTERKEY ASIA

Important dates

Study start
2021
Primary completion
2027
Study completion
2030
First posted
Feb 1, 2022
Registry last updated
Mar 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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