Tumor Disease Including Colorectal CancerNCT03485638
Assessment and Prediction of Cetuximab-Induced Hypersensitivity Reactions Using Cetuximab Specific IgE Detection
An observational study of Tumor Disease Including Colorectal Cancer and Head & Neck Squamous Cell Carcinoma, run by Yonsei University at 1 site in South Korea.
Trial summary
1. Background Cetuximab (trade name Erbitux) is a murine-human chimeric monoclonal antibody to human epidermal growth factor receptor (EGFR). This drug has been used as a treatment for colorectal cancer and head and neck cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tumor Disease Including Colorectal Cancer, Head & Neck Squamous Cell Carcinoma
- How many people
- 400 participants
- Where
- 1 siteSouth Korea
- Study dates
- 4 Nov 2016to 3 Nov 2020
- How long will I take part?
- 4 Weeks
- 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 scheduled for Cetuximab administration according to standard treatment guidelines for the treatment of underlying tumor disease.
Who may be able to join
- Adult men and women over 18 years of age
- Patients scheduled for cetuximab administration according to standard treatment guidelines for the treatment of underlying tumor disease.
Who cannot join
- Patients who did not consent to the study voluntarily after IRB approval
- Persons who are vulnerable (including persons with disabilities, lack of physician capacity, pregnant status, persons who are accommodated in facilities, etc.)
- Those who can not read and understand the agreement
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Division of Allergy and Immunology, Department of Internal Medicine, Yonsei University
Seoul, 03722
Jungwon Park, MD, +82 10 7389 3033, PARKJW@yuhs.ac
About this study
- Background Cetuximab (trade name Erbitux) is a murine-human chimeric monoclonal antibody to human epidermal growth factor receptor (EGFR). This drug has been used as a treatment for colorectal cancer and head and neck cancer. It is known that allergic reactions can occur in more than 5% of the patients, although the side effects are relatively low compared with other chemotherapeutic agents. It is known that cetuximab can induce hypersensitivity even at the first administration, unlike other anticancer drugs. In this study, we aimed to establish a model to predict patients with hypersensitivity reaction before administration of cetuximab and to provide safe chemotherapy.
- Recruitment method and consent procedure The study is designed for analysis patients scheduled for administration of cetuximab for the first time. Patients matching the selection and exclusion criteria with voluntary agreement to the study will be enrolled. Enrolled patients will be tested for skin prick test and serum sIgE before cetuximab administration.
Read the detailed description
- Acquisition of agreement Agreement, explanation, and consent form for study of human derived sample those that approved by the IRB are obtained from patients who prospectively voluntarily participate in the study and provide human derived sample.
- Observation and evaluation values ① Serum Cetuximab-specific IgE measurement (ImmunoCAP, conventional ELISA) before administration of cetuximab ② Cetuximab Skin test using before cetuximab administration ③ Clinical symptoms after cetuximab administration through chart review (vital signs, occurrence of adverse drug reaction) ④ Check patient's underlying disease and allergy history
- Statistical analysis method Chi-square test, Fisher's exact test, Student t-test, Mann-Whitney test, Logistic regression test, Cox's regression test, and ROC curve will be used
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cetuximab administration | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypersensitivity reaction after cetuximab administration
Adverse drug reaction after Cetuximab administration includes severe systemic allergic reaction such as anaphylaxis, urticaria, skin rash, dyspnea, shock and mental change.
Measured: Within 4 weeks after first administration
Secondary outcomes (1)
Cetuximab specific IgE
Cetuximab specific IgE measured by ImmunoCAP assay, ELISA
Measured: within 4 weeks after first administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2018
- Study start4 Nov 2016
- Primary completion3 Nov 2020 (estimated)
- Study completion3 Nov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Tumor Disease Including Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- 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
- 400 participants (estimated)
- Target duration
- 4 Weeks
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03485638
- Sponsor's protocol ID
- 4-2016-0811
- Status last verified
- Mar 2019
- First submitted
- 26 Mar 2018
- Last updated
- 2 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
George TJ Jr, Laplant KD, Walden EO, Davis AB, Riggs CE, Close JL, George SN, Lynch JW. Managing cetuximab hypersensitivity-infusion reactions: incidence, risk factors, prevention, and retreatment. J Support Oncol. 2010 Mar-Apr;8(2):72-7.
PubMed 20464886Hansen NL, Chandiramani DV, Morse MA, Wei D, Hedrick NE, Hansen RA. Incidence and predictors of cetuximab hypersensitivity reactions in a North Carolina academic medical center. J Oncol Pharm Pract. 2011 Jun;17(2):125-30. doi: 10.1177/1078155209360853. Epub 2010 Feb 10.
PubMed 20147576Chung CH, Mirakhur B, Chan E, Le QT, Berlin J, Morse M, Murphy BA, Satinover SM, Hosen J, Mauro D, Slebos RJ, Zhou Q, Gold D, Hatley T, Hicklin DJ, Platts-Mills TA. Cetuximab-induced anaphylaxis and IgE specific for galactose-alpha-1,3-galactose. N Engl J Med. 2008 Mar 13;358(11):1109-17. doi: 10.1056/NEJMoa074943.
PubMed 18337601Pointreau Y, Commins SP, Calais G, Watier H, Platts-Mills TA. Fatal infusion reactions to cetuximab: role of immunoglobulin e-mediated anaphylaxis. J Clin Oncol. 2012 Jan 20;30(3):334; author reply 335. doi: 10.1200/JCO.2011.38.4701. Epub 2011 Dec 12. No abstract available.
PubMed 22162592Mariotte D, Dupont B, Gervais R, Galais MP, Laroche D, Tranchant A, Comby E, Bouhier-Leporrier K, Reimund JM, Le Mauff B. Anti-cetuximab IgE ELISA for identification of patients at a high risk of cetuximab-induced anaphylaxis. MAbs. 2011 Jul-Aug;3(4):396-401. doi: 10.4161/mabs.3.4.16293. Epub 2011 Jul 1.
PubMed 21654207Maier S, Chung CH, Morse M, Platts-Mills T, Townes L, Mukhopadhyay P, Bhagavatheeswaran P, Racenberg J, Trifan OC. A retrospective analysis of cross-reacting cetuximab IgE antibody and its association with severe infusion reactions. Cancer Med. 2015 Jan;4(1):36-42. doi: 10.1002/cam4.333. Epub 2014 Oct 9.
PubMed 25296628Jerath MR, Kwan M, Kannarkat M, Mirakhur B, Carey L, Valgus J, Platts-Mills TA, Tarrant TK. A desensitization protocol for the mAb cetuximab. J Allergy Clin Immunol. 2009 Jan;123(1):260-2. doi: 10.1016/j.jaci.2008.09.046. Epub 2008 Nov 20. No abstract available.
PubMed 19022494
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment and Prediction of Cetuximab-Induced Hypersensitivity Reactions Using Cetuximab Specific IgE Detection
- ClinicalTrials.gov ID
- NCT03485638
- Acronym / sponsor ID
- 4-2016-0811
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 4 Nov 2016 (actual)
- Primary completion
- 3 Nov 2020 (estimated)
- Study completion
- 3 Nov 2020 (estimated)
- First posted
- 2 Apr 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.
- Background Cetuximab (trade name Erbitux) is a murine-human chimeric monoclonal antibody to human epidermal growth factor receptor (EGFR). This drug has been used as a treatment for colorectal cancer and head and neck cancer. It is known that allergic reactions can occur in more than 5% of the patients, although the side effects are relatively low compared with other chemotherapeutic agents. It is known that cetuximab can induce hypersensitivity even at the first administration, unlike other anticancer drugs. In this study, we aimed to establish a model to predict patients with hypersensitivity reaction before administration of cetuximab and to provide safe chemotherapy.
- Recruitment method and consent procedure The study is designed for analysis patients scheduled for administration of cetuximab for the first time. Patients matching the selection and exclusion criteria with voluntary agreement to the study will be enrolled. Enrolled patients will be tested for skin prick test and serum sIgE before cetuximab administration.
Detailed description
- Acquisition of agreement Agreement, explanation, and consent form for study of human derived sample those that approved by the IRB are obtained from patients who prospectively voluntarily participate in the study and provide human derived sample.
- Observation and evaluation values ① Serum Cetuximab-specific IgE measurement (ImmunoCAP, conventional ELISA) before administration of cetuximab ② Cetuximab Skin test using before cetuximab administration ③ Clinical symptoms after cetuximab administration through chart review (vital signs, occurrence of adverse drug reaction) ④ Check patient's underlying disease and allergy history
- Statistical analysis method Chi-square test, Fisher's exact test, Student t-test, Mann-Whitney test, Logistic regression test, Cox's regression test, and ROC curve will be used
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 4 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cetuximab administration | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for Cetuximab administration according to standard treatment guidelines for the treatment of underlying tumor disease.
Key inclusion criteria (2 listed)
- Adult men and women over 18 years of age
- Patients scheduled for cetuximab administration according to standard treatment guidelines for the treatment of underlying tumor disease.
Key exclusion criteria (3 listed)
- Patients who did not consent to the study voluntarily after IRB approval
- Persons who are vulnerable (including persons with disabilities, lack of physician capacity, pregnant status, persons who are accommodated in facilities, etc.)
- Those who can not read and understand the agreement
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Hypersensitivity reaction after cetuximab administration
Time frame: Within 4 weeks after first administration
Adverse drug reaction after Cetuximab administration includes severe systemic allergic reaction such as anaphylaxis, urticaria, skin rash, dyspnea, shock and mental change.
1 secondary outcome
Cetuximab specific IgE
Time frame: within 4 weeks after first administration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2019.
- Background: PubMed 20464886George TJ Jr, Laplant KD, Walden EO, Davis AB, Riggs CE, Close JL, George SN, Lynch JW. Managing cetuximab hypersensitivity-infusion reactions: incidence, risk factors, prevention, and retreatment. J Support Oncol. 2010 Mar-Apr;8(2):72-7.
- Background: PubMed 20147576Hansen NL, Chandiramani DV, Morse MA, Wei D, Hedrick NE, Hansen RA. Incidence and predictors of cetuximab hypersensitivity reactions in a North Carolina academic medical center. J Oncol Pharm Pract. 2011 Jun;17(2):125-30. doi: 10.1177/1078155209360853. Epub 2010 Feb 10.
- Background: PubMed 18337601Chung CH, Mirakhur B, Chan E, Le QT, Berlin J, Morse M, Murphy BA, Satinover SM, Hosen J, Mauro D, Slebos RJ, Zhou Q, Gold D, Hatley T, Hicklin DJ, Platts-Mills TA. Cetuximab-induced anaphylaxis and IgE specific for galactose-alpha-1,3-galactose. N Engl J Med. 2008 Mar 13;358(11):1109-17. doi: 10.1056/NEJMoa074943.
- Background: PubMed 22162592Pointreau Y, Commins SP, Calais G, Watier H, Platts-Mills TA. Fatal infusion reactions to cetuximab: role of immunoglobulin e-mediated anaphylaxis. J Clin Oncol. 2012 Jan 20;30(3):334; author reply 335. doi: 10.1200/JCO.2011.38.4701. Epub 2011 Dec 12. No abstract available.
- Background: PubMed 21654207Mariotte D, Dupont B, Gervais R, Galais MP, Laroche D, Tranchant A, Comby E, Bouhier-Leporrier K, Reimund JM, Le Mauff B. Anti-cetuximab IgE ELISA for identification of patients at a high risk of cetuximab-induced anaphylaxis. MAbs. 2011 Jul-Aug;3(4):396-401. doi: 10.4161/mabs.3.4.16293. Epub 2011 Jul 1.
- Background: PubMed 25296628Maier S, Chung CH, Morse M, Platts-Mills T, Townes L, Mukhopadhyay P, Bhagavatheeswaran P, Racenberg J, Trifan OC. A retrospective analysis of cross-reacting cetuximab IgE antibody and its association with severe infusion reactions. Cancer Med. 2015 Jan;4(1):36-42. doi: 10.1002/cam4.333. Epub 2014 Oct 9.
- Background: PubMed 19022494Jerath MR, Kwan M, Kannarkat M, Mirakhur B, Carey L, Valgus J, Platts-Mills TA, Tarrant TK. A desensitization protocol for the mAb cetuximab. J Allergy Clin Immunol. 2009 Jan;123(1):260-2. doi: 10.1016/j.jaci.2008.09.046. Epub 2008 Nov 20. No abstract available.
- 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.
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 Tumor Disease Including Colorectal Cancer and Head & Neck Squamous Cell Carcinoma, run by Yonsei University at 1 site in South Korea.
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 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: status not confirmed, as of the sponsor's last update on 2 Apr 2019. 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 South Korea. 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 Jungwon Park, MD (+82 10 7389 3033, PARKJW@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hypersensitivity reaction after cetuximab administration (time frame: Within 4 weeks after first administration). 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 NCT03485638, which also lists 7 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 2 Apr 2019.