Colorectal Cancer MetastaticOPTIPAL-IINCT03750175
OPTImal PALliative Anti-epidermal Growth Factor Receptor Treatment in Metastatic Colorectal Cancer -
An observational study of Colorectal Cancer Metastatic and Circulating Tumor DNA, run by Karen-Lise Garm Spindler at 1 site in Denmark.
Trial summary
The present study will investigate the feasibility and clinical value of using circulating tumor DNA as selection for anti-epidermal growth factor receptor treatment for metastatic colorectal cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer Metastatic, Circulating Tumor DNA, KRAS Gene Mutation
- What is being tested?
- Plasma circulating DNA analysis
- How many people
- 49 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jun 2018to 31 Dec 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 with metastatic colorectal cancer and indication for palliative chemotherapy with potential anti-EGFR monoclonal antibody.
Who may be able to join
- Histopathologically verified metastatic colorectal cancer
- Indication for systemic palliative treatment with standard Anti-EGFR monoclonal antibodies
- Fit for therapy with EGFR inhibition
- Consent to treatment and sampling
- Measureable disease according to RECIST v 1.1
- Age ≥ 18
Who cannot join
- PS > 2
- Significant other cancer disease within 5 years of inclusion
- Conditions precluding sampling during therapy and treatment breaks.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: OPTImal PALliative Anti-epidermal Growth Factor Receptor Treatment in Metastatic Colorectal Cancer - Feasibility Study Investigating Circulating Tumor DNA for Treatment Decisions
The present study will investigate the feasibility and clinical value of using circulating tumor DNA as selection for anti-epidermal growth factor receptor treatment for metastatic colorectal cancer.
Read the detailed description
The primary aim of this prospective study is to investigate if cfDNA in plasma is feasible and reliable for selection of mCRC patients who will benefit of anti-EGFR monoclonal antibody therapy
Secondary, to analyze developments in mutational status as reflected by cfDNA in plasma during therapy and at time of progression
- Conditions
- Colorectal Cancer Metastatic, Circulating Tumor DNA, KRAS Gene Mutation, NRAS Gene Mutation, BRAF Gene Mutation, Epidermal Growth Factor Receptor Inhibitor
- Being tested
- Plasma circulating DNA analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plasma circulating DNA analysisOther
Clinical utility of ctDNA analysis for treatment decision
| Study group | Role | What they receive |
|---|---|---|
| Colorectal cancer patients | Clinical utility of ctDNA analysis for treatment decision
Use of ctDNA for KRAS, NRAS and BRAF testing prior to potential anti-EGFR monoclonal antibody treatment for metastatic colorectal cancer Receives: Other: Plasma circulating DNA analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of ctDNA analysis for RAS mutation analysis
Feasibility measures
Identification of wildtype or mutated status and results delivered to clinicians
- Initial clinical test results i.e. ctDNA mutations or wildtype status within 7 days
- Detailed mutation type characterization is provided retrospectively.
Failure parameters
- Quality of samples; PB > 5%, CPP1 major loss < 10%
- Transportation > 3 week days
- Analysis > 3 working days
- Total results delivered > 7 days.
Measured: maximum 7 days
Secondary outcomes (5)
Retrospective concordance analysis
Retrospective comparison of tumor mutation and plasma mutation analysis at baseline
Measured: By end of study, expected after 3 years
Disease control rate
Rate of disease control
Measured: 1 year
OS
Overall survival rate
Measured: 3 years
Resistance mutations
Rate of Ectoderm mutations at time of progression
Measured: At time of progression, data analysis expected after 3 years
Lead time
Calcualted lead time between radiologically detected progression and molecular biologically detected ( by Ectoderm and other resistance mutations) in the ctDNA.
Measured: At time of progression, data analysis expected after 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2018
- Study start1 Jun 2018
- Primary completion1 Jun 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal Cancer MetastaticStudies 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
- Prospective
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karen-Lise Garm Spindler
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Karen-Lise Garm Spindler, Aarhus University Hospital
- Investigators
- Karen-Lise G Spindler, Study chair, Department of Oncology, AUH, Dk
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03750175
- Sponsor's protocol ID
- KFE1713
- Acronym
- OPTIPAL-II
- Status last verified
- Feb 2023
- First submitted
- 27 Sep 2018
- Last updated
- 3 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Callesen LB, Sorensen BS, Pallisgaard N, Laugesen IG, Boysen AK, Spindler KG. Total cell-free DNA measurement in metastatic colorectal cancer with a fast and easy direct fluorescent assay. Mol Clin Oncol. 2022 Mar;16(3):64. doi: 10.3892/mco.2022.2497. Epub 2022 Jan 17.
PubMed 35154704
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OPTImal PALliative Anti-epidermal Growth Factor Receptor Treatment in Metastatic Colorectal Cancer - Feasibility Study Investigating Circulating Tumor DNA for Treatment Decisions
- ClinicalTrials.gov ID
- NCT03750175
- Acronym / sponsor ID
- OPTIPAL-II / KFE1713
- Conditions
- Colorectal Cancer Metastatic, Circulating Tumor DNA, KRAS Gene Mutation, NRAS Gene Mutation, BRAF Gene Mutation, Epidermal Growth Factor Receptor Inhibitor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Karen-Lise Garm SpindlerUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 21 Nov 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.
The present study will investigate the feasibility and clinical value of using circulating tumor DNA as selection for anti-epidermal growth factor receptor treatment for metastatic colorectal cancer.
Detailed description
The primary aim of this prospective study is to investigate if cfDNA in plasma is feasible and reliable for selection of mCRC patients who will benefit of anti-EGFR monoclonal antibody therapy
Secondary, to analyze developments in mutational status as reflected by cfDNA in plasma during therapy and at time of progression
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Colorectal cancer patients | – | Other: Plasma circulating DNA analysisClinical utility of ctDNA analysis for treatment decision Use of ctDNA for KRAS, NRAS and BRAF testing prior to potential anti-EGFR monoclonal antibody treatment for metastatic colorectal cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with metastatic colorectal cancer and indication for palliative chemotherapy with potential anti-EGFR monoclonal antibody.
Key inclusion criteria (6 listed)
- Histopathologically verified metastatic colorectal cancer
- Indication for systemic palliative treatment with standard Anti-EGFR monoclonal antibodies
- Fit for therapy with EGFR inhibition
- Consent to treatment and sampling
- Measureable disease according to RECIST v 1.1
Key exclusion criteria (3 listed)
- PS > 2
- Significant other cancer disease within 5 years of inclusion
- Conditions precluding sampling during therapy and treatment breaks.
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 |
|---|---|---|
| Plasma circulating DNA analysisClinical utility of ctDNA analysis for treatment decision | Other | Colorectal cancer patients |
Primary outcome
Feasibility of ctDNA analysis for RAS mutation analysis
Time frame: maximum 7 days
Feasibility measures Identification of wildtype or mutated status and results delivered to clinicians * Initial clinical test results i.e. ctDNA mutations or wildtype status within 7 days * Detailed mutation type characterization is provided retrospectively. Failure parameters * Quality of samples; PB > 5%, CPP1 major loss < 10% * Transportation > 3 week days * Analysis > 3 working days * Total results delivered > 7 days.
5 secondary outcomes
Retrospective concordance analysis
Time frame: By end of study, expected after 3 years
Disease control rate
Time frame: 1 year
OS
Time frame: 3 years
Resistance mutations
Time frame: At time of progression, data analysis expected after 3 years
Lead time
Time frame: At time of progression, data analysis expected after 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2023.
- Derived from this study: PubMed 35154704Callesen LB, Sorensen BS, Pallisgaard N, Laugesen IG, Boysen AK, Spindler KG. Total cell-free DNA measurement in metastatic colorectal cancer with a fast and easy direct fluorescent assay. Mol Clin Oncol. 2022 Mar;16(3):64. doi: 10.3892/mco.2022.2497. Epub 2022 Jan 17.
- Individual participant dataSharing planned: No
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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.
Karen-Lise G Spindler study chair
Department of Oncology, AUH, Dk
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 Metastatic and Circulating Tumor DNA, run by Karen-Lise Garm Spindler at 1 site in Denmark.
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 3 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: finished, as of the sponsor's last update on 3 Feb 2023. 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 Denmark. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Feasibility of ctDNA analysis for RAS mutation analysis (time frame: maximum 7 days). 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 NCT03750175, which also lists 1 linked publication.
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 3 Feb 2023.