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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorNational Cancer Center, Japan

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

None

Trial population

Malignancies with an annual incidence of less than 6 cases per 100,000 population; malignancies categorized as rare cancers in the European RARECARE report; malignancies that are difficult to develop treatments; common cancers with rare tissue subtypes; common cancers that can be regarded as rare based on biological demographics such as age or sex; and cancers of unknow primary are eligible for this study.

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

  • Genomic sequence

    Other intervention

    Genomic sequence

Treatment groups

1,000 Participants
are divided into 2 treatment groups
Group A: Rare cancer1 intervention
Group B: Cholangiocarcinoma cohort1 intervention

Trial outcomes

Primary outcomes

1

Overall incidence of any genomic alteration in overall population

Overall incidence of any genomic alteration in overall population

Time frame
1 year
2

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

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

Time frame
1 year

Secondary outcomes

1

Incidence of individual genomic alteration in overall population

The incidence of individual genomic alterations in overall population

Time frame
1 year
2

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

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

Time frame
1 year

Other outcomes

1

Biomarker positive proportion in overall population

The proportion of patients positive for certain biomarkers in overall population

Time frame
1 year
2

Biomarker positive proportion in patients with a certain cancer type

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

Time frame
1 year
3

Number of somatic variants within exons in overall population

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

Time frame
1 year
4

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

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

Time frame
1 year

Sponsors and contacts

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