Colorectal CancerNCT04863768
Molecular Profiling of Colorectal Cancer
An observational study of Colorectal Cancer and Colon Cancer, run by Hellenic Cooperative Oncology Group at 1 site in Greece.
Trial summary
In this translational research study, Formalin-Fixed-Paraffin-Embedded (FFPE) tumor tissue blocks from patients with early-stage (II-III) colorectal cancer will be assessed for a comprehensive cancer gene panel from NIPD Genetics (https://www.nipd.com/) targeting regions in 37 clinically relevant cancer genes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Colon Cancer, Colon Adenocarcinoma
- What is being tested?
- Gene panel
- How many people
- 300 participants
- Where
- 1 siteGreece
- Study dates
- 1 Jan 2006to Sep 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who underwent surgical resection of early-stage (II-III) colorectal cancer
Who may be able to join
- Surgically resected early-stage (II-III) colorectal cancer
- Availability of biological material
Who cannot join
- Metastatic disease (stage IV) at initial diagnosis
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
Hellenic Cooperative Oncology Group
Athens, 11526
Hellenic Cooperative O Group, 6977018142, georgexoinis@gmail.com
About this study
Official title: Molecular Profiling of Colorectal Cancer: A Translational Research Study With a Next Generation Sequencing Panel.
In this translational research study, Formalin-Fixed-Paraffin-Embedded (FFPE) tumor tissue blocks from patients with early-stage (II-III) colorectal cancer will be assessed for a comprehensive cancer gene panel from NIPD Genetics (https://www.nipd.com/) targeting regions in 37 clinically relevant cancer genes.
The colorectal cancer panel includes an extended list of clinically relevant genes, designed to target clinically actionable and clinically significant mutations that will provide physicians with genetic information regarding a) prediction of the patient's response to targeted therapy, b) prognosis, that is, prediction of clinical outcome, c) diagnosis and molecular classification of colorectal cancer.
- Conditions
- Colorectal Cancer, Colon Cancer, Colon Adenocarcinoma
- Being tested
- Gene panel
- Keywords
- Colon, Translational research, Gene panel
- Medical subject headings
- Colorectal Neoplasms, Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gene panelDiagnostic test
comprehensive cancer gene panel targeting regions in 37 clinically relevant cancer genes in FFPE tumor tissue blocks
What is being measured
The primary outcome is the main question the study is designed to answer.
association between gene mutational status and overall survival
the time from diagnosis to the date of death (from any cause). Alive patients and patients lost to follow-up will be censored at the date of last follow-up
Measured: 24 months
association between gene mutational status and disease-free survival
the time from colorectal cancer diagnosis to the first date of documented disease progression, death or last contact, whichever occurs first
Measured: 24 months
Secondary outcomes (3)
Descriptives
Association of any gene mutation tumor pathological stages.
Measured: 24 months
Descriptives
Association of any gene mutation tumor budding.
Measured: 24 months
Descriptives
Association of any gene mutation with microstatellite instability.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2021
- Study start1 Jan 2006
- Primary completionSep 2021 (estimated)
- Study completionSep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Colorectal 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hellenic Cooperative Oncology Group
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- George Fountzilas, Prof, Study chair, Hellenic Cooperative Oncology Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04863768
- Sponsor's protocol ID
- TR6N/19
- Status last verified
- Mar 2021
- First submitted
- 12 Mar 2021
- Last updated
- 28 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Dekker E, Tanis PJ, Vleugels JLA, Kasi PM, Wallace MB. Colorectal cancer. Lancet. 2019 Oct 19;394(10207):1467-1480. doi: 10.1016/S0140-6736(19)32319-0.
PubMed 31631858Seufferlein T, Simoes C, Kude F, Ettrich TJ. Molecular Approaches to Metastatic Colorectal Cancer: Better Diagnosis - Better Treatment? Visc Med. 2019 Aug;35(4):259-264. doi: 10.1159/000500617. Epub 2019 Jul 11.
PubMed 31602389Khan K, Valeri N, Dearman C, Rao S, Watkins D, Starling N, Chau I, Cunningham D. Targeting EGFR pathway in metastatic colorectal cancer- tumour heterogeniety and convergent evolution. Crit Rev Oncol Hematol. 2019 Nov;143:153-163. doi: 10.1016/j.critrevonc.2019.09.001. Epub 2019 Sep 7.
PubMed 31678702Cohen R, Rousseau B, Vidal J, Colle R, Diaz LA Jr, Andre T. Immune Checkpoint Inhibition in Colorectal Cancer: Microsatellite Instability and Beyond. Target Oncol. 2020 Feb;15(1):11-24. doi: 10.1007/s11523-019-00690-0.
PubMed 31786718Caputo F, Santini C, Bardasi C, Cerma K, Casadei-Gardini A, Spallanzani A, Andrikou K, Cascinu S, Gelsomino F. BRAF-Mutated Colorectal Cancer: Clinical and Molecular Insights. Int J Mol Sci. 2019 Oct 28;20(21):5369. doi: 10.3390/ijms20215369.
PubMed 31661924Oh HH, Joo YE. Novel biomarkers for the diagnosis and prognosis of colorectal cancer. Intest Res. 2020 Apr;18(2):168-183. doi: 10.5217/ir.2019.00080. Epub 2019 Nov 30.
PubMed 31766836De Roock W, Claes B, Bernasconi D, De Schutter J, Biesmans B, Fountzilas G, Kalogeras KT, Kotoula V, Papamichael D, Laurent-Puig P, Penault-Llorca F, Rougier P, Vincenzi B, Santini D, Tonini G, Cappuzzo F, Frattini M, Molinari F, Saletti P, De Dosso S, Martini M, Bardelli A, Siena S, Sartore-Bianchi A, Tabernero J, Macarulla T, Di Fiore F, Gangloff AO, Ciardiello F, Pfeiffer P, Qvortrup C, Hansen TP, Van Cutsem E, Piessevaux H, Lambrechts D, Delorenzi M, Tejpar S. Effects of KRAS, BRAF, NRAS, and PIK3CA mutations on the efficacy of cetuximab plus chemotherapy in chemotherapy-refractory metastatic colorectal cancer: a retrospective consortium analysis. Lancet Oncol. 2010 Aug;11(8):753-62. doi: 10.1016/S1470-2045(10)70130-3. Epub 2010 Jul 8.
PubMed 20619739Strimpakos A, Pentheroudakis G, Kotoula V, De Roock W, Kouvatseas G, Papakostas P, Makatsoris T, Papamichael D, Andreadou A, Sgouros J, Zizi-Sermpetzoglou A, Kominea A, Televantou D, Razis E, Galani E, Pectasides D, Tejpar S, Syrigos K, Fountzilas G. The prognostic role of ephrin A2 and endothelial growth factor receptor pathway mediators in patients with advanced colorectal cancer treated with cetuximab. Clin Colorectal Cancer. 2013 Dec;12(4):267-274.e2. doi: 10.1016/j.clcc.2013.07.001. Epub 2013 Sep 17.
PubMed 24050852Pentheroudakis G, Kotoula V, De Roock W, Kouvatseas G, Papakostas P, Makatsoris T, Papamichael D, Xanthakis I, Sgouros J, Televantou D, Kafiri G, Tsamandas AC, Razis E, Galani E, Bafaloukos D, Efstratiou I, Bompolaki I, Pectasides D, Pavlidis N, Tejpar S, Fountzilas G. Biomarkers of benefit from cetuximab-based therapy in metastatic colorectal cancer: interaction of EGFR ligand expression with RAS/RAF, PIK3CA genotypes. BMC Cancer. 2013 Feb 2;13:49. doi: 10.1186/1471-2407-13-49.
PubMed 23374602Pagani F, Randon G, Guarini V, Raimondi A, Prisciandaro M, Lobefaro R, Di Bartolomeo M, Sozzi G, de Braud F, Gasparini P, Pietrantonio F. The Landscape of Actionable Gene Fusions in Colorectal Cancer. Int J Mol Sci. 2019 Oct 25;20(21):5319. doi: 10.3390/ijms20215319.
PubMed 31731495Itatani Y, Kawada K, Yamamoto T, Sakai Y. Resistance to Anti-Angiogenic Therapy in Cancer-Alterations to Anti-VEGF Pathway. Int J Mol Sci. 2018 Apr 18;19(4):1232. doi: 10.3390/ijms19041232.
PubMed 29670046Pentheroudakis G, Mavroeidis L, Papadopoulou K, Koliou GA, Bamia C, Chatzopoulos K, Samantas E, Mauri D, Efstratiou I, Pectasides D, Makatsoris T, Bafaloukos D, Papakostas P, Papatsibas G, Bombolaki I, Chrisafi S, Kourea HP, Petraki K, Kafiri G, Fountzilas G, Kotoula V. Angiogenic and Antiangiogenic VEGFA Splice Variants in Colorectal Cancer: Prospective Retrospective Cohort Study in Patients Treated With Irinotecan-Based Chemotherapy and Bevacizumab. Clin Colorectal Cancer. 2019 Dec;18(4):e370-e384. doi: 10.1016/j.clcc.2019.07.007. Epub 2019 Jul 15.
PubMed 31402291Pentheroudakis G, Kotoula V, Fountzilas E, Kouvatseas G, Basdanis G, Xanthakis I, Makatsoris T, Charalambous E, Papamichael D, Samantas E, Papakostas P, Bafaloukos D, Razis E, Christodoulou C, Varthalitis I, Pavlidis N, Fountzilas G. A study of gene expression markers for predictive significance for bevacizumab benefit in patients with metastatic colon cancer: a translational research study of the Hellenic Cooperative Oncology Group (HeCOG). BMC Cancer. 2014 Feb 20;14:111. doi: 10.1186/1471-2407-14-111.
PubMed 24555920Koutras AK, Antonacopoulou AG, Eleftheraki AG, Dimitrakopoulos FI, Koumarianou A, Varthalitis I, Fostira F, Sgouros J, Briasoulis E, Bournakis E, Bafaloukos D, Bompolaki I, Galani E, Kalogeras KT, Pectasides D, Fountzilas G, Kalofonos HP. Vascular endothelial growth factor polymorphisms and clinical outcome in colorectal cancer patients treated with irinotecan-based chemotherapy and bevacizumab. Pharmacogenomics J. 2012 Dec;12(6):468-75. doi: 10.1038/tpj.2011.37. Epub 2011 Aug 16.
PubMed 21844885Stratton MR, Campbell PJ, Futreal PA. The cancer genome. Nature. 2009 Apr 9;458(7239):719-24. doi: 10.1038/nature07943.
PubMed 19360079
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Profiling of Colorectal Cancer: A Translational Research Study With a Next Generation Sequencing Panel.
- ClinicalTrials.gov ID
- NCT04863768
- Acronym / sponsor ID
- TR6N/19
- Conditions
- Colorectal Cancer, Colon Cancer, Colon Adenocarcinoma
- Keywords
- Colon, Translational research, Gene panel
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Hellenic Cooperative Oncology GroupUniversity, hospital or other
- Study start
- 1 Jan 2006 (actual)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Sep 2022 (estimated)
- First posted
- 28 Apr 2021 (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.
In this translational research study, Formalin-Fixed-Paraffin-Embedded (FFPE) tumor tissue blocks from patients with early-stage (II-III) colorectal cancer will be assessed for a comprehensive cancer gene panel from NIPD Genetics (https://www.nipd.com/) targeting regions in 37 clinically relevant cancer genes.
The colorectal cancer panel includes an extended list of clinically relevant genes, designed to target clinically actionable and clinically significant mutations that will provide physicians with genetic information regarding a) prediction of the patient's response to targeted therapy, b) prognosis, that is, prediction of clinical outcome, c) diagnosis and molecular classification of colorectal cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent surgical resection of early-stage (II-III) colorectal cancer
Key inclusion criteria (2 listed)
- Surgically resected early-stage (II-III) colorectal cancer
- Availability of biological material
Key exclusion criteria (1 listed)
- Metastatic disease (stage IV) at initial diagnosis
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 |
|---|---|---|
| Gene panelcomprehensive cancer gene panel targeting regions in 37 clinically relevant cancer genes in FFPE tumor tissue blocks | Diagnostic test | – |
Primary outcome
association between gene mutational status and overall survival
Time frame: 24 months
the time from diagnosis to the date of death (from any cause). Alive patients and patients lost to follow-up will be censored at the date of last follow-up
association between gene mutational status and disease-free survival
Time frame: 24 months
the time from colorectal cancer diagnosis to the first date of documented disease progression, death or last contact, whichever occurs first
3 secondary outcomes
Descriptives
Time frame: 24 months
Descriptives
Time frame: 24 months
Descriptives
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2021.
- Background: PubMed 31631858Dekker E, Tanis PJ, Vleugels JLA, Kasi PM, Wallace MB. Colorectal cancer. Lancet. 2019 Oct 19;394(10207):1467-1480. doi: 10.1016/S0140-6736(19)32319-0.
- Background: PubMed 31602389Seufferlein T, Simoes C, Kude F, Ettrich TJ. Molecular Approaches to Metastatic Colorectal Cancer: Better Diagnosis - Better Treatment? Visc Med. 2019 Aug;35(4):259-264. doi: 10.1159/000500617. Epub 2019 Jul 11.
- Background: PubMed 31678702Khan K, Valeri N, Dearman C, Rao S, Watkins D, Starling N, Chau I, Cunningham D. Targeting EGFR pathway in metastatic colorectal cancer- tumour heterogeniety and convergent evolution. Crit Rev Oncol Hematol. 2019 Nov;143:153-163. doi: 10.1016/j.critrevonc.2019.09.001. Epub 2019 Sep 7.
- Background: PubMed 31786718Cohen R, Rousseau B, Vidal J, Colle R, Diaz LA Jr, Andre T. Immune Checkpoint Inhibition in Colorectal Cancer: Microsatellite Instability and Beyond. Target Oncol. 2020 Feb;15(1):11-24. doi: 10.1007/s11523-019-00690-0.
- Background: PubMed 31661924Caputo F, Santini C, Bardasi C, Cerma K, Casadei-Gardini A, Spallanzani A, Andrikou K, Cascinu S, Gelsomino F. BRAF-Mutated Colorectal Cancer: Clinical and Molecular Insights. Int J Mol Sci. 2019 Oct 28;20(21):5369. doi: 10.3390/ijms20215369.
- Background: PubMed 31766836Oh HH, Joo YE. Novel biomarkers for the diagnosis and prognosis of colorectal cancer. Intest Res. 2020 Apr;18(2):168-183. doi: 10.5217/ir.2019.00080. Epub 2019 Nov 30.
- Background: PubMed 20619739De Roock W, Claes B, Bernasconi D, De Schutter J, Biesmans B, Fountzilas G, Kalogeras KT, Kotoula V, Papamichael D, Laurent-Puig P, Penault-Llorca F, Rougier P, Vincenzi B, Santini D, Tonini G, Cappuzzo F, Frattini M, Molinari F, Saletti P, De Dosso S, Martini M, Bardelli A, Siena S, Sartore-Bianchi A, Tabernero J, Macarulla T, Di Fiore F, Gangloff AO, Ciardiello F, Pfeiffer P, Qvortrup C, Hansen TP, Van Cutsem E, Piessevaux H, Lambrechts D, Delorenzi M, Tejpar S. Effects of KRAS, BRAF, NRAS, and PIK3CA mutations on the efficacy of cetuximab plus chemotherapy in chemotherapy-refractory metastatic colorectal cancer: a retrospective consortium analysis. Lancet Oncol. 2010 Aug;11(8):753-62. doi: 10.1016/S1470-2045(10)70130-3. Epub 2010 Jul 8.
- Background: PubMed 24050852Strimpakos A, Pentheroudakis G, Kotoula V, De Roock W, Kouvatseas G, Papakostas P, Makatsoris T, Papamichael D, Andreadou A, Sgouros J, Zizi-Sermpetzoglou A, Kominea A, Televantou D, Razis E, Galani E, Pectasides D, Tejpar S, Syrigos K, Fountzilas G. The prognostic role of ephrin A2 and endothelial growth factor receptor pathway mediators in patients with advanced colorectal cancer treated with cetuximab. Clin Colorectal Cancer. 2013 Dec;12(4):267-274.e2. doi: 10.1016/j.clcc.2013.07.001. Epub 2013 Sep 17.
- Background: PubMed 23374602Pentheroudakis G, Kotoula V, De Roock W, Kouvatseas G, Papakostas P, Makatsoris T, Papamichael D, Xanthakis I, Sgouros J, Televantou D, Kafiri G, Tsamandas AC, Razis E, Galani E, Bafaloukos D, Efstratiou I, Bompolaki I, Pectasides D, Pavlidis N, Tejpar S, Fountzilas G. Biomarkers of benefit from cetuximab-based therapy in metastatic colorectal cancer: interaction of EGFR ligand expression with RAS/RAF, PIK3CA genotypes. BMC Cancer. 2013 Feb 2;13:49. doi: 10.1186/1471-2407-13-49.
- Background: PubMed 31731495Pagani F, Randon G, Guarini V, Raimondi A, Prisciandaro M, Lobefaro R, Di Bartolomeo M, Sozzi G, de Braud F, Gasparini P, Pietrantonio F. The Landscape of Actionable Gene Fusions in Colorectal Cancer. Int J Mol Sci. 2019 Oct 25;20(21):5319. doi: 10.3390/ijms20215319.
- Background: PubMed 29670046Itatani Y, Kawada K, Yamamoto T, Sakai Y. Resistance to Anti-Angiogenic Therapy in Cancer-Alterations to Anti-VEGF Pathway. Int J Mol Sci. 2018 Apr 18;19(4):1232. doi: 10.3390/ijms19041232.
- Background: PubMed 31402291Pentheroudakis G, Mavroeidis L, Papadopoulou K, Koliou GA, Bamia C, Chatzopoulos K, Samantas E, Mauri D, Efstratiou I, Pectasides D, Makatsoris T, Bafaloukos D, Papakostas P, Papatsibas G, Bombolaki I, Chrisafi S, Kourea HP, Petraki K, Kafiri G, Fountzilas G, Kotoula V. Angiogenic and Antiangiogenic VEGFA Splice Variants in Colorectal Cancer: Prospective Retrospective Cohort Study in Patients Treated With Irinotecan-Based Chemotherapy and Bevacizumab. Clin Colorectal Cancer. 2019 Dec;18(4):e370-e384. doi: 10.1016/j.clcc.2019.07.007. Epub 2019 Jul 15.
- Individual participant dataSharing planned: Undecided
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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.
George Fountzilas, Prof study chair
Hellenic Cooperative Oncology Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer and Colon Cancer, run by Hellenic Cooperative Oncology Group at 1 site in Greece.
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 2 inclusion and 1 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 28 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. 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?
Contact George Papaxoinis (+302106409000, georgexoinis@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
association between gene mutational status and overall survival (time frame: 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04863768, which also lists 21 linked publications.
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 28 Apr 2021.