Squamous CarcinomaMORRISNCT02379039
Multimodal Monitoring of Radiotherapy Response in Squamous Cell Cancer
An observational study of Squamous Carcinoma and Head and Neck Cancer, run by Umeå University at 1 site in Sweden.
Trial summary
The study's aim is to define imaging and molecular bio-markers for prediction of radiotherapy response of squamous cell carcinomas, in an early treatment phase. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Squamous Carcinoma, Head and Neck Cancer, Anal Cancer
- How many people
- 118 participants
- Where
- 1 siteSweden
- Study dates
- May 2015to May 2023
- 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 previously untreated squamous carcinoma aimed for radiotherapy with curative intent of the oral cavity, oropharynx, uterine cervix, oesophagus, anal canal or lung.
Who may be able to join
- Morphologically (pathology or cytology) verified, previously untreated squamous cell carcinoma (SCC) of the oral cavity, oropharynx, uterine cervix, oesophagus or lung.
- The patient should be planned for treatment with radiotherapy alone or in combination with concomitant medical therapy
- The tumour shall be radiologically and/or visually identifiable and accessible for biopsy without the need for general anaesthesia or other major interventions
- The patient must be at least 18 years of age, able to understand the given information and, leave a written informed consent to participate
Who cannot join
- The patient is unwilling to participate in the study
- Patients with adjuvant post-operative radiotherapy (i.e. no visible remaining tumour)
- Pregnancy or lactation
- Contraindications to investigations with MRI, gadolinium contrast or PET-tracers
- Patients with an estimated glomerular filtration rate (GFR) <60 ml/min/1.73m2.
- Severe co-morbidities that are judged to significantly compromise survival in a two-years perspective.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multimodal Monitoring of Radiotherapy Response in Squamous Cell Cancer in Head & Neck, Lung, Oesophagus, Anal Canal and Uterine Cervix - a Basis for Personalised Radiotherapy
The study's aim is to define imaging and molecular bio-markers for prediction of radiotherapy response of squamous cell carcinomas, in an early treatment phase.
Read the detailed description
Patients with squamous cell carcinoma of the head \& neck, anal canal, cervix, esophagus or lung will be assessed before start of radiotherapy and 1-2 weeks after start. Multi-parametric MRI and 18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose (18F-FDG) positron emission tomography (PET) will be performed in parallel to metabolomic analyses of tumour tissue. The investigators will correlate changes in imaging bio-markers to corresponding changes in tissue or blood bio-markers by repeated imaging and biopsies for better understanding of the image parameters.
The data from the two assessments will be used for identifying imaging bio-markers, predictive for outcome. The patient data will be divided into one set of data for hypothesis generation and another set for validation.
- Conditions
- Squamous Carcinoma, Head and Neck Cancer, Anal Cancer, Lung Cancer, Esophageal Cancer, Cervix Cancer
- Medical subject headings
- Carcinoma, Squamous Cell, Head and Neck Neoplasms, Anus Neoplasms, Lung Neoplasms, Esophageal Neoplasms, Uterine Cervical Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Loco regional control
After completion of radiotherapy
Measured: 2 years
Secondary outcomes (5)
Loco regional tumour control (response)
After completion of radiotherapy
Measured: 2 months
Patterns of failure
Time and location of recurrence
Measured: 2 years
Overall survival
After completion of radiotherapy
Measured: 5 years
Changes in imaging and metabolic data
As measured 1-2 weeks after start of radiotherapy
Measured: 1-2 weeks
Site specific toxicity
Measured as patient reported side-effects
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2015 (estimated)
- Study startMay 2015
- Primary completionMay 2023
- Study completionMay 2023
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 Squamous CarcinomaStudies of the same condition, open and under way.
- More trials run by Umeå 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Collaborators
- Lund University
- Responsible party
- Sponsor
- Investigators
- Björn Zackrisson, Professor, Principal investigator, Umeå University, Department of Radiation Sciences - Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02379039
- Sponsor's protocol ID
- MORRIS_1
- Acronym
- MORRIS
- Status last verified
- Dec 2023
- First submitted
- 26 Feb 2015
- Last updated
- 22 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: If relevant, anonymized data may be shared.
Publications
Strandberg S, Jonsson J, Zarei M, Aglund K, Blomqvist L, Soderkvist K. Baseline and early response 2-[18F]FDG-PET/MRI for prediction of radiotherapy outcome in uterine cervical squamous cell carcinoma: a prospective single-center observational cohort study. EJNMMI Rep. 2024 Mar 1;8(1):5. doi: 10.1186/s41824-024-00188-7.
PubMed 38748271
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Monitoring of Radiotherapy Response in Squamous Cell Cancer in Head & Neck, Lung, Oesophagus, Anal Canal and Uterine Cervix - a Basis for Personalised Radiotherapy
- ClinicalTrials.gov ID
- NCT02379039
- Acronym / sponsor ID
- MORRIS / MORRIS_1
- Conditions
- Squamous Carcinoma, Head and Neck Cancer, Anal Cancer, Lung Cancer, Esophageal Cancer, Cervix Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Collaborators
- Lund University
- Study start
- May 2015
- Primary completion
- May 2023 (actual)
- Study completion
- May 2023 (actual)
- First posted
- 4 Mar 2015 (estimated)
- 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 study's aim is to define imaging and molecular bio-markers for prediction of radiotherapy response of squamous cell carcinomas, in an early treatment phase.
Detailed description
Patients with squamous cell carcinoma of the head \& neck, anal canal, cervix, esophagus or lung will be assessed before start of radiotherapy and 1-2 weeks after start. Multi-parametric MRI and 18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose (18F-FDG) positron emission tomography (PET) will be performed in parallel to metabolomic analyses of tumour tissue. The investigators will correlate changes in imaging bio-markers to corresponding changes in tissue or blood bio-markers by repeated imaging and biopsies for better understanding of the image parameters.
The data from the two assessments will be used for identifying imaging bio-markers, predictive for outcome. The patient data will be divided into one set of data for hypothesis generation and another set for validation.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with previously untreated squamous carcinoma aimed for radiotherapy with curative intent of the oral cavity, oropharynx, uterine cervix, oesophagus, anal canal or lung.
Key inclusion criteria (4 listed)
- Morphologically (pathology or cytology) verified, previously untreated squamous cell carcinoma (SCC) of the oral cavity, oropharynx, uterine cervix, oesophagus or lung.
- The patient should be planned for treatment with radiotherapy alone or in combination with concomitant medical therapy
- The tumour shall be radiologically and/or visually identifiable and accessible for biopsy without the need for general anaesthesia or other major interventions
- The patient must be at least 18 years of age, able to understand the given information and, leave a written informed consent to participate
Key exclusion criteria (6 listed)
- The patient is unwilling to participate in the study
- Patients with adjuvant post-operative radiotherapy (i.e. no visible remaining tumour)
- Pregnancy or lactation
- Contraindications to investigations with MRI, gadolinium contrast or PET-tracers
- Patients with an estimated glomerular filtration rate (GFR) <60 ml/min/1.73m2.
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
Loco regional control
Time frame: 2 years
After completion of radiotherapy
5 secondary outcomes
Loco regional tumour control (response)
Time frame: 2 months
Patterns of failure
Time frame: 2 years
Overall survival
Time frame: 5 years
Changes in imaging and metabolic data
Time frame: 1-2 weeks
Site specific toxicity
Time frame: 1 year
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 22 Dec 2023.
- Derived from this study: PubMed 38748271Strandberg S, Jonsson J, Zarei M, Aglund K, Blomqvist L, Soderkvist K. Baseline and early response 2-[18F]FDG-PET/MRI for prediction of radiotherapy outcome in uterine cervical squamous cell carcinoma: a prospective single-center observational cohort study. EJNMMI Rep. 2024 Mar 1;8(1):5. doi: 10.1186/s41824-024-00188-7.
- Individual participant dataSharing planned: Yes. If relevant, anonymized data may be shared.
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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.
Björn Zackrisson, Professor principal investigator
Umeå University, Department of Radiation Sciences - Oncology
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 Squamous Carcinoma and Head and Neck Cancer, run by Umeå University at 1 site in Sweden.
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 4 inclusion and 6 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 22 Dec 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 Sweden. 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?
Loco regional control (time frame: 2 years). 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 NCT02379039, 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 22 Dec 2023.