Rare Malignant Neoplasm
Conditions
Keywords
Rare cancer, Rare subtype, Registry, Asia, Next-generation sequencing
Brief summary
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.
Interventions
OTHERGenomic sequence
Genomic sequence
Sponsors
National Cancer Center, Japan
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 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.) 2. Patients with Advanced stage cancer.
Exclusion criteria
1\. Patients with complications of cognitive impairment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall incidence of any genomic alteration in overall population | 1 year | Overall incidence of any genomic alteration in overall population |
| Overall incidence of any genomic alteration in patients with a certain cancer type | 1 year | Overall incidence of any genomic alteration in patients with a certain cancer type |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of individual genomic alteration in overall population | 1 year | The incidence of individual genomic alterations in overall population |
| Incidence of individual genomic alteration in patients with a certain cancer type | 1 year | The incidence of individual genomic alterations in patients with a certain cancer type |
Other
| Measure | Time frame | Description |
|---|---|---|
| Response rate in patients treated with biomarker/genomic alteration-based therapy | 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. |
| Response rate in patients treated with a therapy other than biomarker/genomic alteration-based therapy | 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. |
| Response rate in patients treated with immune checkpoint inhibitors | 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. |
| Disease control rate in patients treated with biomarker/genomic alteration-based therapy | 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. |
| Biomarker positive proportion in overall population | 1 year | The proportion of patients positive for certain biomarkers in overall population |
| Disease control rate in patients treated with immune checkpoint inhibitors | 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. |
| Overall survival | 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. |
| Progression-free survival | 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. |
| Proportion of patients receiving no treatment with observation-only in real-world clinical practice | 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. |
| Disease control rate in patients treated with a therapy other than biomarker/genomic alteration-based therapy | 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. |
| Biomarker positive proportion in patients with a certain cancer type | 1 year | The proportion of patients positive for certain biomarkers in patients with a certain cancer type |
| Number of somatic variants within exons in overall population | 1 year | The number of somatic variants and proportion of variants in overall population |
| Number of somatic variants within exons in patients with a certain cancer type | 1 year | The number of somatic variants and proportion of variants in patients with a certain cancer type |
Countries
Japan, Malaysia, Philippines, South Korea, Taiwan, Thailand, Vietnam
Contacts
Primary ContactChiharu Mizoguchi, MD
Backup ContactHitomi Okuma, MD, PhD
Outcome results
None listed