CancerNCT03724097
Identification of Molecular Biomarkers for Cancer Target Therapy Efficacy
An observational study of Cancer, run by OmicsWay Corp. at 7 sites in 2 countries.
Trial summary
This is a prospective trial for a computation-based efficacy prediction method for anticancer target therapies. The original computational algorithm utilizes individual transcriptome data of a cancer sample and assesses changes at the level of gene expression and intracellular signaling pathways. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cancer
- What is being tested?
- RNA sequencing, Transcriptome analysis and target drug with the score above 0,1
- How many people
- 200 participants
- Where
- 7 sitesin 2 countries
- Study dates
- 17 Oct 2017to 1 Nov 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Oncological patients
Who may be able to join
- Adults, diagnosed with cancer;
- Age 18 - 80;
- Patients who previously received anticancer treatment within the standard care, patients for whom standard therapy was not indicated or patients refused to receive standard therapy. Patients could receive an unlimited number of treatment lines before this study;
- Available formalin fixed, paraffin-embedded (FFPE) samples of cancer tissue. The material should be confirmed by a certified pathologist, the sample taken for the analysis should contain at least 70% of tumor cells;
- Anticipated survival of at least 3 months since the patient's inclusion in the current investigation;
- Patients who have signed an informed consent.
Who cannot join
- Anticipated survival of less than 3 months since the patient's inclusion in the current investigation;
- Lack of tumor biopsy material, inability to obtain a new tumor biopsy.
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
Russia6 sites
Kaluga Regional Clinical Oncology Center
Kaluga, 248007
Oncological Clinical Dispensary No. 1 of the Moscow City Health Department
Moscow, 105005
Multidisciplinary medical holding "SM-Clinic"
Moscow, 109316
N.N. Blokhin National Medical Research Center of Oncology
Moscow, 115478
"Oncobox" Ltd.
Moscow, 121205
Vitamed LLC
Moscow, 121309
About this study
This is a prospective trial for a computation-based efficacy prediction method for anticancer target therapies. The original computational algorithm utilizes individual transcriptome data of a cancer sample and assesses changes at the level of gene expression and intracellular signaling pathways. By applying the database of known molecular targets of anticancer target drugs it allows to rank potential efficacies of target drugs.
Read the detailed description
Original computational algorithm Oncobox was developed to determine molecular features of individual tumors. It represents the solution for a personalized selection of target anticancer therapies. The method is based on the analysis of gene expression profile of a cancer sample in comparison with the corresponding normal tissue biosamples in order to select the most effective molecular targets for their inhibition and, accordingly, to identify more effective target drugs for cancer treatment. Histological material obtained from cancer patients during surgery or core-needle biopsy as part of standard treatment will be used for the analysis. Total RNA extracted from the tumor material will be subjected to next-generation sequencing (NGS). By comparing transcriptome profile of the tumor sample with the profiles of the corresponding normal tissue samples the rate of molecular pathways activation/deactivation will be calculated, as well as the case-to-normal ratios for the individual gene products - molecular targets of drugs. Based on these data, each target drug will be assigned with a score reflecting its potential efficacy for each individual tumor treatment. A drug with the score value above 0.1 will be considered potentially effective, a drug with the score value equal to or below 0.1 - as potentially ineffective. Following Oncobox test, 130 target anticancer drugs will be rated according to their predicted effectiveness (see the list of eligible target drugs below). This information will be fully available to a patient and his/her doctor. The doctor will prescribe treatment according to his/her consideration, e.g. based on the standards of care and the patient's life indications. After the appointment of therapy, the patients will be divided naturally into the following three observation groups. The first group will be formed from patients receiving target drugs with the score value above 0,1 as monotherapy or in combination. The second group - patients receiving only non-target drugs or target drugs with the score value equal to or below 0,1 as monotherapy or in combination. Third group will be formed by patients receiving palliative care. Within this study, these three groups will be compared by response to the therapy according to the results of instrumental studies, by time to progression and by time to progression compared to the previous line of therapy (if any). Additionally, overall survival will be measured in all three groups.
Eligible target drugs:
- Abemaciclib (LY2835219)
- Afatinib
- Aflibercept
- Alectinib
- Alemtuzumab
- Alitretinoin
- Anastrozole
- Apalutamide, ARN-509
- Arsenic trioxide
- Atezolizumab
- Avelumab
- Axitinib
- Belinostat
- Bevacizumab
- Bexarotene
- Bicalutamide
- Binimetinib (MEK162)
- Blinatumomab
- Bortezomib
- Bosutinib
- Brentuximab vedotin
- Brigatinib
- Cabazitaxel
- Cabozantinib
- Carfilzomib
- Ceritinib (Zykadia, LDK378)
- Cetuximab
- Cobimetinib
- Crizotinib
- CYT387 (Momelotinib)
- Dabrafenib
- Daratumumab
- Dasatinib
- Degarelix
- Denileukin diftitox (Ontac)
- Denosumab
- Docetaxel
- Dovitinib
- Durvalumab
- Elotuzumab
- Encorafenib
- Enzalutamide
- Erlotinib
- Estramustine
- Everolimus
- Exemestane
- Flavopiridol (Alvociclib)
- Foretinib
- Fulvestrant
- Ganetespib (STA-9090)
- Gefitinib
- Goserelin
- Homoharringtonine (Omacetaxine mepesuccinate)
- Ibritumomab tiuxetan
- Ibrutinib
- Idelalisib
- Imatinib
- Inotuzumab ozogamicin
- Ipilimumab
- Ixabepilone
- Ixazomib (MLN9708)
- Lapatinib
- Lenalidomide
- Lenvatinib
- Letrozole
- Leuprolide
- Lomustine
- Masitinib
- Medroxyprogesterone acetate (MPA)
- Megestrol
- Methyltestosterone
- Midostaurin
- Mogamulizumab
- Moxetumomab pasudotox
- Necitumumab
- Nilotinib
- Nilutamide
- Nimotuzumab
- Nintedanib (BIBF 1120)
- Niraparib
- Nivolumab (BMS-936558)
- Obinutuzumab
- Ofatumumab
- Olaparib
- Olaratumab
- Osimertinib
- Paclitaxel
- Palbociclib
- Panitumumab
- Panobinostat
- Pazopanib
- Pembrolizumab
- Perifosine
- Pertuzumab
- Pomalidomide
- Ponatinib
- Ramucirumab (Cyramza)
- Regorafenib
- Ribociclib
100. Rigosertib 101. Rituximab 102. Romidepsin 103. Rucaparib 104. Ruxolitinib 105. Selumetinib 106. Siltuximab 107. Sonidegib (LDE225) 108. Sorafenib 109. Sunitinib 110. Tamoxifen 111. Tecemotide (Emepepimut-S, L-BLP25) 112. Temozolomide 113. Temsirolimus 114. Thalidomide 115. Tivantinib 116. Tivozanib 117. Toremifene 118. Trametinib (Mekinst) 119. Trastuzumab 120. Trebananib 121. Vandetanib 122. Veliparib 123. Vemurafenib 124. Venetoclax 125. Vinblastine 126. Vincristine 127. Vindesine 128. Vinorelbine 129. Vismodegib 130. Vorinostat
- Conditions
- Cancer
- Being tested
- RNA sequencing, Transcriptome analysis, target drug with the score above 0,1, target drug with the score equal or below 0,1, non-target drug
- Keywords
- biomarkers, target therapy, NGS, RNAseq, mRNA, transcriptome analysis, signaling pathway, intracellular molecular pathway, Oncobox, Next generation sequencing, RNA sequencing
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RNA sequencingOther
Also called RNA-seq
Next Generation Sequencing of RNA from tumor samples, rRNA-depleted.
Transcriptome analysisOther
Analysis of RNA-seq data using the Oncobox algorithm.
target drug with the score above 0,1Drug
target drug with the score above 0,1
target drug with the score equal or below 0,1Drug
target drug with the score equal or below 0,1
non-target drugDrug
non-target drug
palliative careDrug
palliative care
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Patients receiving target drugs with the score value above 0,1 as monotherapy or in combination Receives: Other: RNA sequencing; Other: Transcriptome analysis; Drug: target drug with the score above 0,1 | |
| Group 2 | Patients receiving only non-target drugs or target drugs with the score value equal to or below 0,1 as monotherapy or in combination Receives: Other: RNA sequencing; Other: Transcriptome analysis; Drug: target drug with the score equal or below 0,1; Drug: non-target drug | |
| Group 3 | Patients receiving palliative care Receives: Other: RNA sequencing; Other: Transcriptome analysis; Drug: palliative care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor response
Tumor response according to the results of instrumental studies
Measured: 2 years
Time to progression
Time to progression
Measured: 2 years
Time to progression compared to the previous therapy lane
Time to progression compared to the previous therapy lane
Measured: 2 years
Secondary outcomes (1)
Overall survival
Overall survival
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2018
- Study start17 Oct 2017
- Primary completion1 Apr 2021
- Study completion1 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- OmicsWay Corp.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Oncobox Ltd, Vitamed LLC, N.N. Blokhin National Medical Research Center of Oncology, Kaluga Regional Clinical Oncology Center, Multidisciplinary medical holding SM-Clinic, Oncological Clinical Dispensary No. 1 of the Moscow City Health Department
- Responsible party
- Sponsor
- Investigators
- Anton A Buzdin, Ph.D., D.Sc, Principal investigator, OmicsWay Corp.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03724097
- Sponsor's protocol ID
- OB0052018
- Status last verified
- Sep 2021
- First submitted
- 26 Oct 2018
- Last updated
- 14 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study Protocol, Statistical Analysis Plan (SAP), NGS data, Clinical Study Report (CSR)
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Molecular Biomarkers for Cancer Target Therapy Efficacy
- ClinicalTrials.gov ID
- NCT03724097
- Acronym / sponsor ID
- OB0052018
- Conditions
- Cancer
- Keywords
- biomarkers, target therapy, NGS, RNAseq, mRNA, transcriptome analysis, signaling pathway, intracellular molecular pathway
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- OmicsWay Corp.Industry (pharma, biotech, devices)
- Collaborators
- Oncobox Ltd, Vitamed LLC, N.N. Blokhin National Medical Research Center of Oncology, Kaluga Regional Clinical Oncology Center, Multidisciplinary medical holding SM-Clinic, Oncological Clinical Dispensary No. 1 of the Moscow City Health Department
- Study start
- 17 Oct 2017 (actual)
- Primary completion
- 1 Apr 2021 (actual)
- Study completion
- 1 Nov 2022 (estimated)
- First posted
- 30 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective trial for a computation-based efficacy prediction method for anticancer target therapies. The original computational algorithm utilizes individual transcriptome data of a cancer sample and assesses changes at the level of gene expression and intracellular signaling pathways. By applying the database of known molecular targets of anticancer target drugs it allows to rank potential efficacies of target drugs.
Detailed description
Original computational algorithm Oncobox was developed to determine molecular features of individual tumors. It represents the solution for a personalized selection of target anticancer therapies. The method is based on the analysis of gene expression profile of a cancer sample in comparison with the corresponding normal tissue biosamples in order to select the most effective molecular targets for their inhibition and, accordingly, to identify more effective target drugs for cancer treatment. Histological material obtained from cancer patients during surgery or core-needle biopsy as part of standard treatment will be used for the analysis. Total RNA extracted from the tumor material will be subjected to next-generation sequencing (NGS). By comparing transcriptome profile of the tumor sample with the profiles of the corresponding normal tissue samples the rate of molecular pathways activation/deactivation will be calculated, as well as the case-to-normal ratios for the individual gene products - molecular targets of drugs. Based on these data, each target drug will be assigned with a score reflecting its potential efficacy for each individual tumor treatment. A drug with the score value above 0.1 will be considered potentially effective, a drug with the score value equal to or below 0.1 - as potentially ineffective. Following Oncobox test, 130 target anticancer drugs will be rated according to their predicted effectiveness (see the list of eligible target drugs below). This information will be fully available to a patient and his/her doctor. The doctor will prescribe treatment according to his/her consideration, e.g. based on the standards of care and the patient's life indications. After the appointment of therapy, the patients will be divided naturally into the following three observation groups. The first group will be formed from patients receiving target drugs with the score value above 0,1 as monotherapy or in combination. The second group - patients receiving only non-target drugs or target drugs with the score value equal to or below 0,1 as monotherapy or in combination. Third group will be formed by patients receiving palliative care. Within this study, these three groups will be compared by response to the therapy according to the results of instrumental studies, by time to progression and by time to progression compared to the previous line of therapy (if any). Additionally, overall survival will be measured in all three groups.
Eligible target drugs:
- Abemaciclib (LY2835219)
- Afatinib
- Aflibercept
- Alectinib
- Alemtuzumab
- Alitretinoin
- Anastrozole
- Apalutamide, ARN-509
- Arsenic trioxide
- Atezolizumab
- Avelumab
- Axitinib
- Belinostat
- Bevacizumab
- Bexarotene
- Bicalutamide
- Binimetinib (MEK162)
- Blinatumomab
- Bortezomib
- Bosutinib
- Brentuximab vedotin
- Brigatinib
- Cabazitaxel
- Cabozantinib
- Carfilzomib
- Ceritinib (Zykadia, LDK378)
- Cetuximab
- Cobimetinib
- Crizotinib
- CYT387 (Momelotinib)
- Dabrafenib
- Daratumumab
- Dasatinib
- Degarelix
- Denileukin diftitox (Ontac)
- Denosumab
- Docetaxel
- Dovitinib
- Durvalumab
- Elotuzumab
- Encorafenib
- Enzalutamide
- Erlotinib
- Estramustine
- Everolimus
- Exemestane
- Flavopiridol (Alvociclib)
- Foretinib
- Fulvestrant
- Ganetespib (STA-9090)
- Gefitinib
- Goserelin
- Homoharringtonine (Omacetaxine mepesuccinate)
- Ibritumomab tiuxetan
- Ibrutinib
- Idelalisib
- Imatinib
- Inotuzumab ozogamicin
- Ipilimumab
- Ixabepilone
- Ixazomib (MLN9708)
- Lapatinib
- Lenalidomide
- Lenvatinib
- Letrozole
- Leuprolide
- Lomustine
- Masitinib
- Medroxyprogesterone acetate (MPA)
- Megestrol
- Methyltestosterone
- Midostaurin
- Mogamulizumab
- Moxetumomab pasudotox
- Necitumumab
- Nilotinib
- Nilutamide
- Nimotuzumab
- Nintedanib (BIBF 1120)
- Niraparib
- Nivolumab (BMS-936558)
- Obinutuzumab
- Ofatumumab
- Olaparib
- Olaratumab
- Osimertinib
- Paclitaxel
- Palbociclib
- Panitumumab
- Panobinostat
- Pazopanib
- Pembrolizumab
- Perifosine
- Pertuzumab
- Pomalidomide
- Ponatinib
- Ramucirumab (Cyramza)
- Regorafenib
- Ribociclib
100. Rigosertib 101. Rituximab 102. Romidepsin 103. Rucaparib 104. Ruxolitinib 105. Selumetinib 106. Siltuximab 107. Sonidegib (LDE225) 108. Sorafenib 109. Sunitinib 110. Tamoxifen 111. Tecemotide (Emepepimut-S, L-BLP25) 112. Temozolomide 113. Temsirolimus 114. Thalidomide 115. Tivantinib 116. Tivozanib 117. Toremifene 118. Trametinib (Mekinst) 119. Trastuzumab 120. Trebananib 121. Vandetanib 122. Veliparib 123. Vemurafenib 124. Venetoclax 125. Vinblastine 126. Vincristine 127. Vindesine 128. Vinorelbine 129. Vismodegib 130. Vorinostat
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Other: RNA sequencing, Other: Transcriptome analysis, Drug: target drug with the score above 0,1Patients receiving target drugs with the score value above 0,1 as monotherapy or in combination |
| Group 2 | – | Other: RNA sequencing, Other: Transcriptome analysis, Drug: target drug with the score equal or below 0,1, Drug: non-target drugPatients receiving only non-target drugs or target drugs with the score value equal to or below 0,1 as monotherapy or in combination |
| Group 3 | – | Other: RNA sequencing, Other: Transcriptome analysis, Drug: palliative carePatients receiving palliative care |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Oncological patients
Key inclusion criteria (6 listed)
- Adults, diagnosed with cancer;
- Age 18 - 80;
- Patients who previously received anticancer treatment within the standard care, patients for whom standard therapy was not indicated or patients refused to receive standard therapy. Patients could receive an unlimited number of treatment lines before this study;
- Available formalin fixed, paraffin-embedded (FFPE) samples of cancer tissue. The material should be confirmed by a certified pathologist, the sample taken for the analysis should contain at least 70% of tumor cells;
- Anticipated survival of at least 3 months since the patient's inclusion in the current investigation;
Key exclusion criteria (2 listed)
- Anticipated survival of less than 3 months since the patient's inclusion in the current investigation;
- Lack of tumor biopsy material, inability to obtain a new tumor biopsy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RNA sequencingAlso: RNA-seqNext Generation Sequencing of RNA from tumor samples, rRNA-depleted. | Other | Group 1, Group 2, Group 3 |
| Transcriptome analysisAnalysis of RNA-seq data using the Oncobox algorithm. | Other | Group 1, Group 2, Group 3 |
| target drug with the score above 0,1target drug with the score above 0,1 | Drug | Group 1 |
| target drug with the score equal or below 0,1target drug with the score equal or below 0,1 | Drug | Group 2 |
| non-target drugnon-target drug | Drug | Group 2 |
| palliative carepalliative care | Drug | Group 3 |
Primary outcome
Tumor response
Time frame: 2 years
Tumor response according to the results of instrumental studies
Time to progression
Time frame: 2 years
Time to progression
Time to progression compared to the previous therapy lane
Time frame: 2 years
Time to progression compared to the previous therapy lane
1 secondary outcome
Overall survival
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2021.
- Individual participant dataSharing planned: Yes. Study Protocol, Statistical Analysis Plan (SAP), NGS data, Clinical Study Report (CSR)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anton A Buzdin, Ph.D., D.Sc principal investigator
OmicsWay Corp.
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by OmicsWay Corp. at 7 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Russia, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumor response (time frame: 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2021.