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.

This study is a part of MASTER KEY Asia study and designed to be conducted on the patients of cholangiocarcinoma only. The primary endpoint is assigned to the frequency of FGFR2 fusion gene positive cholangiocarcinoma detected by fluorescence in situ hybridization (FISH) in Asian countries. The genetic analysis is performed not only by FISH, but also by next generation sequencing (NGS), so that genetic alterations other than the FGFR2 fusion gene in alterations can be confirmed. To improve outcomes, collecting clinical information is very important to study the relationship between genetic alterations and prognosis, effect of treatments, and the incidence of genomic alterations in cholangiocarcinoma to discover more specific and effective treatment.

Genomic sequence

Chiharu Mizoguchi, MD

Hitomi Okuma, MD, PhD

Noboru Yamamoro, MD, PhD

Kan Yonemori, MD, PhD

Kenichi Nakamura, MD, PhD

Yuta Maruki, MD

Takuji Okusaka, MD, PhD

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.

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

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

The proportion of patients positive for certain biomarkers in overall population

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

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

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

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 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 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 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 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.

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 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 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 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.

Overall incidence of any genomic alteration in overall population

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

The incidence of individual genomic alterations in overall population

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

National Cancer Center, Japan

Neoplasms

All Conditions

Mouth and Tooth Diseases

Rare Diseases

Carcinoma

Salivary Gland Neoplasms

Carcinoma, Adenoid Cystic

Mouth Neoplasms

Head and Neck Neoplasms

Mouth Diseases

Stomatognathic Diseases

Salivary Gland Diseases

Adenoid Cystic Carcinoma

Oral Cancer

All Drugs and Chemicals

Gallium 68 PSMA-11

Radiopharmaceuticals

On the scheduled visit date for the study,

* An intravenous cannula (plug) will be inserted in a vein in the participant's arm, through which the 68-Ga PSMA radiotracer for the scan will be injected. The infusion will take about 1-2 minutes.
* PET imaging will be performed with a dedicated PET/CT scanner. 2.5-6.0 mCi (depending on weight of the patient) of PSMA radiotracer will be injected intravenously.

68-Ga PSMA PET scan

Dr Wen-Long NEI, MD

The objectives of this pilot feasibility study, which is on the use of 68-Ga PSMA PET imaging of salivary gland tumours, are

* to determine the proportion of patients with high PSMA-ligand uptake on Ga-68 PSMA imaging in locally advanced, recurrent or metastatic salivary gland cancers and other rare cancer; and
* to determine if in vitro PSMA expression correlates to PSMA-ligand uptake on Ga-68 PSMA imaging in locally advanced, recurrent or metastatic salivary gland cancers and other rare cancers.

The hypotheses of this study are that there is high PSMA-ligand uptake on Ga-68 PSMA imaging in locally advanced, recurrent or metastatic salivary gland cancers and other rare cancers; and that in vitro PSMA expression correlates to PSMA-ligand uptake on Ga-68 PSMA imaging.

The potential participant will be screened and confirmed for eligibility by the appropriate study-team member. A signed IRB approved informed consent will be obtained prior to conducting any study-related procedures.

On the scheduled visit date for the study,

* An intravenous cannula (plug) will be inserted in a vein in the participant's arm, through which the 68-Ga PSMA radiotracer for the scan will be injected. The infusion will take about 1-2 minutes.
* PET imaging will be performed with a dedicated PET/CT scanner. 2.5-6.0 mCi (depending on weight of the patient) of PSMA radiotracer will be injected intravenously.
* A PET scan will be done around 60 minutes after the injection of the 68-Ga PSMA imaging agent.
* During imaging, the participant will be asked to lie still and may be asked to hold his/her breath for a few seconds.
* Imaging will be performed using a PET/CT, which will take 30 to 40 minutes to complete. Imaging of the body from vertex to mid thigh or feet will be obtained.
* After the completion of the scan, the plug will be removed.

A Final Study Visit will take place on that one scheduled day. The participant will not need to visit the doctor's office during the course of the study outside of their usual scheduled doctor's follow up appointments.

PSMA-PET Imaging of Salivary Gland Tumours and Other Rare Cancers

The proportion of patients with PSMA-ligand uptake greater than liver uptake on Ga-68 PSMA imaging in locally advanced, recurrent or metastatic salivary gland cancers and other rare cancer.

Correlation between the value of IHC PSMA expression and the PSMA PET SUVmax in locally advanced, recurrent or metastatic salivary gland cancers and other rare cancers.

National Cancer Centre, Singapore

Antineoplastic Agents

Amino Acids

Imatinib Mesylate

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

treatment according to genetic alterations

imatinib treatment based on molecular alterations

Imatinib

Åslaug Helland

Elisa Bjørgo

Åslaug Helland, MD PhD

Some rare cancers are hard-to-treat and patients have a poor prognosis. It is known that some of these patients have targetable molecular alterations, and some benefit from targeted drugs. However in many cases these drugs are not approved for the rare cancers.

In this study the aim is to do advanced molecular diagnostics to identify possible targets for therapy, and to treat accordingly.

All patients will have the tumour cells diagnosed with a large genepanel, analyzing more than 500 genes on DNA / RNA level. Patients will be treated based on the molecular characteristics of the tumor cells.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Marker Assisted Selective ThErapy in Rare Cancers: Knowledge Database Establishing registrY Asia	NCT05217407	Rare Malignant ...	Genomic sequenc...	18 Years -	National Cancer Center, Japan
PSMA-PET Imaging of Salivary Gland Tumours and Other Rare Cancers	NCT05581979	Salivary Gland ... Rare Malignant ...	68-Ga PSMA PET ...	21 Years - 99 Years	National Cancer Centre, Singapore
PSMA-PET Imaging of Salivary Gland Tumours and Other Rare Cancers	NCT05581979	Salivary Gland ... Rare Malignant ...	68-Ga PSMA PET ...	21 Years - 99 Years	National Cancer Centre, Singapore
Precision Cancer Therapy in Rare Cancers	NCT06119789	Rare Malignant ...	Imatinib	16 Years - 99 Years	Oslo University Hospital
Precision Cancer Therapy in Rare Cancers	NCT06119789	Rare Malignant ...	Imatinib	16 Years - 99 Years	Oslo University Hospital

Spots Global Cancer Trial Database for rare malignant neoplasm