Locally Advanced Cervical CarcinomaMETEOR-CRATRNCT05975593
MicroEnvironment Tumor Effects of Radiotherapy - Comprehensive Radiobiology Assessment TRial
A study testing Tumor collection via biopsy, Blood collection and Diffusion basis spectrum imaging (DBSI) magnetic resonance imaging (MRI) in people with Locally Advanced Cervical Carcinoma and Locally Advanced Cervical Cancer, run by Washington University School of Medicine at 1 site in United States.
Trial summary
This study is a dynamically adjustable prospective longitudinal study designed to capture biospecimen (biopsy, blood, surgical) and multimodal treatment-related data (imaging, dosimetry, clinical) before, during, and after treatment with definitive-intent chemoradiotherapy for patients with locally advanced cervical… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced Cervical Carcinoma, Locally Advanced Cervical Cancer, Locally Advanced Pancreas Cancer
- What is being tested?
- Tumor collection via biopsy, Blood collection and Diffusion basis spectrum imaging (DBSI) magnetic resonance imaging (MRI)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jan 2024to 31 Dec 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Confirmation of intent to receive radiotherapy for one of the following diagnoses:
- Cervical cancer
- Pancreatic cancer
- ECOG performance status ≤ 2
- At least 18 years old
- Able to understand and willing to sign an IRB-approved written informed consent document
Who cannot join
- Any issue (medical, anatomic, other) that might preclude safe acquisition of biospecimens at the discretion of the treating physician
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Washington University School of Medicine
St Louis, Missouri, 63110
Michael Waters, M.D., Ph.D., 314-273-0275, m.r.waters@wustl.edu
Michael Waters, M.D., Ph.D.
About this study
Official title: MicroEnvironment Tumor Effects of Radiotherapy - Comprehensive Radiobiology Assessment TRial (METEOR-CRATR)
This study is a dynamically adjustable prospective longitudinal study designed to capture biospecimen (biopsy, blood, surgical) and multimodal treatment-related data (imaging, dosimetry, clinical) before, during, and after treatment with definitive-intent chemoradiotherapy for patients with locally advanced cervical and pancreatic cancer.
- Conditions
- Locally Advanced Cervical Carcinoma, Locally Advanced Cervical Cancer, Locally Advanced Pancreas Cancer, Locally Advanced Pancreatic Carcinoma, Locally Advanced Pancreatic Cancer, Cervical Cancer
- Being tested
- Tumor collection via biopsy, Blood collection, Diffusion basis spectrum imaging (DBSI) magnetic resonance imaging (MRI)
- Keywords
- Radiotherapy, Chemotherapy, Cervical cancer, Pancreatic cancer, Biospecimen
- Medical subject headings
- Uterine Cervical Neoplasms, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tumor collection via biopsyOther
Cervical cancer: Pre-radiation therapy, 1 week after beginning radiation therapy, 3 weeks after beginning radiation therapy, and recurrence.
Pancreatic cancer: pre-stereotactic body radiotherapy, 12 weeks after completion of radiotherapy, and recurrence.
Blood collectionOther
Cervical cancer: pre-radiation therapy, 1 week after beginning radiation therapy, 3 weeks after beginning radiation therapy, 6 weeks after completing radiation therapy, 12 weeks after completing radiation therapy, and recurrence.
Pancreatic cancer: pre-stereotactic body radiotherapy, 6 weeks after completion of radiotherapy, 12 weeks after completion of radiotherapy, surgery (if applicable), and recurrence
Diffusion basis spectrum imaging (DBSI) magnetic resonance imaging (MRI)Device
Also called DBSI MRI
Cervical cancer: initial staging, 12 weeks after completing radiation therapy, and recurrence.
Pancreatic cancer: initial staging, stereotactic body radiotherapy (SBRT) simulation, 12 weeks after completing radiation therapy, and recurrence.
The imaging will be performed when possible.
| Study group | Role | What they receive |
|---|---|---|
| Cervical Cancer | Other | * Patients will have blood and tumor collected at various time points throughout participation in the study.
* Patients will have standard of care imaging obtained at various time points and a diffusion basis spectrum imaging (DBSI) MRI will be obtained at the end of standard of care MRI. Receives: Other: Tumor collection via biopsy; Other: Blood collection; Device: Diffusion basis spectrum imaging (DBSI) magnetic resonance imaging (MRI) |
| Pancreatic Cancer | Other | * Patients will have blood and tumor collected at various time points throughout participation in the study.
* Patients will have standard of care imaging obtained at various time points and a diffusion basis spectrum imaging (DBSI) MRI will be obtained at the end of standard of care MRI. Receives: Other: Tumor collection via biopsy; Other: Blood collection; Device: Diffusion basis spectrum imaging (DBSI) magnetic resonance imaging (MRI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in tumor microenvironment
Generalized linear mixed effects models will be first used to capture the changes in the longitudinal values of a single assay output over time for a given biospecimen. Random effects will be used to describe the correlation of repeated measures on the same subject over time.
Measured: From start of follow-up through completion of follow-up (estimated to be 5 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2023
- Study start11 Jan 2024
- Primary completion31 Dec 2032 (estimated)
- Study completion31 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Cervical CarcinomaStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 30 cervical cancer patients and 30 pancreatic cancer patients
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), The Foundation for Barnes-Jewish Hospital
- Responsible party
- Sponsor
- Investigators
- Michael Waters, M.D., Ph.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05975593
- Sponsor's protocol ID
- 202307103
- Other IDs
- U54CA274318
- Acronym
- METEOR-CRATR
- Status last verified
- Aug 2026
- First submitted
- 24 Jul 2023
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Data will be presented at scientific meetings \& published in journals. Individual-level \& aggregate genomic data will be deposited/made available through GEO \& SRA. Includes sequence, transcriptomic, epigenomic, \& gene expression data. Raw mass spectra \& unprocessed proteomic data will be shared through publisher mechanisms. Will use PRIDE \& ProteomeEXchange to share protein identifications \& spectral evidence. METEOR-BLST will collaborate with ROBIN centers to share expertise, data reporting and discovering of radiation biology. Data generated in this proposal will be shared with the scientific community subject to NIH \& institutional regulations. BLST will manage \& assist in dissemination of omics data generated. NIMS data will be deposited at MetaboLights. CODEX-based imaging data will be as supplemental files within manuscripts. Processed data will be available through CIELO. Model organisms generated will be distributed freely, or deposited into a repository/stock center.
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MicroEnvironment Tumor Effects of Radiotherapy - Comprehensive Radiobiology Assessment TRial (METEOR-CRATR)
- ClinicalTrials.gov ID
- NCT05975593
- Acronym / sponsor ID
- METEOR-CRATR / 202307103
- Conditions
- Locally Advanced Cervical Carcinoma, Locally Advanced Cervical Cancer, Locally Advanced Pancreas Cancer, Locally Advanced Pancreatic Carcinoma, Locally Advanced Pancreatic Cancer, Cervical Cancer
- Keywords
- Radiotherapy, Chemotherapy, Cervical cancer, Pancreatic cancer, Biospecimen
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), The Foundation for Barnes-Jewish Hospital
- Study start
- 11 Jan 2024 (actual)
- Primary completion
- 31 Dec 2032 (estimated)
- Study completion
- 31 Dec 2032 (estimated)
- First posted
- 4 Aug 2023 (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 study is a dynamically adjustable prospective longitudinal study designed to capture biospecimen (biopsy, blood, surgical) and multimodal treatment-related data (imaging, dosimetry, clinical) before, during, and after treatment with definitive-intent chemoradiotherapy for patients with locally advanced cervical and pancreatic cancer.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 30 cervical cancer patients and 30 pancreatic cancer patients
| Arm | Type | Receives |
|---|---|---|
| Cervical Cancer | Other | Other: Tumor collection via biopsy, Other: Blood collection, Device: Diffusion basis spectrum imaging (DBSI) magnetic resonance imaging (MRI)* Patients will have blood and tumor collected at various time points throughout participation in the study. * Patients will have standard of care imaging obtained at various time points and a diffusion basis spectrum imaging (DBSI) MRI will be obtained at the end of standard of care MRI. |
| Pancreatic Cancer | Other | Other: Tumor collection via biopsy, Other: Blood collection, Device: Diffusion basis spectrum imaging (DBSI) magnetic resonance imaging (MRI)* Patients will have blood and tumor collected at various time points throughout participation in the study. * Patients will have standard of care imaging obtained at various time points and a diffusion basis spectrum imaging (DBSI) MRI will be obtained at the end of standard of care MRI. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Confirmation of intent to receive radiotherapy for one of the following diagnoses:
- ECOG performance status ≤ 2
- At least 18 years old
- Able to understand and willing to sign an IRB-approved written informed consent document
Key exclusion criteria (1 listed)
- Any issue (medical, anatomic, other) that might preclude safe acquisition of biospecimens at the discretion of the treating physician
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 |
|---|---|---|
| Tumor collection via biopsyCervical cancer: Pre-radiation therapy, 1 week after beginning radiation therapy, 3 weeks after beginning radiation therapy, and recurrence. Pancreatic cancer: pre-stereotactic body radiotherapy, 12 weeks after completion of radiotherapy, and recurrence. | Other | Cervical Cancer, Pancreatic Cancer |
| Blood collectionCervical cancer: pre-radiation therapy, 1 week after beginning radiation therapy, 3 weeks after beginning radiation therapy, 6 weeks after completing radiation therapy, 12 weeks after completing radiation therapy, and recurrence. Pancreatic cancer: pre-stereotactic body radiotherapy, 6 weeks after completion of radiotherapy, 12 weeks after completion of radiotherapy, surgery (if applicable), and recurrence | Other | Cervical Cancer, Pancreatic Cancer |
| Diffusion basis spectrum imaging (DBSI) magnetic resonance imaging (MRI)Also: DBSI MRICervical cancer: initial staging, 12 weeks after completing radiation therapy, and recurrence. Pancreatic cancer: initial staging, stereotactic body radiotherapy (SBRT) simulation, 12 weeks after completing radiation therapy, and recurrence. The imaging will be performed when possible. | Device | Cervical Cancer, Pancreatic Cancer |
Primary outcome
Changes in tumor microenvironment
Time frame: From start of follow-up through completion of follow-up (estimated to be 5 years)
Generalized linear mixed effects models will be first used to capture the changes in the longitudinal values of a single assay output over time for a given biospecimen. Random effects will be used to describe the correlation of repeated measures on the same subject over time.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Data will be presented at scientific meetings \& published in journals. Individual-level \& aggregate genomic data will be deposited/made available through GEO \& SRA. Includes sequence, transcriptomic, epigenomic, \& gene expression data. Raw mass spectra \& unprocessed proteomic data will be shared through publisher mechanisms. Will use PRIDE \& ProteomeEXchange to share protein identifications \& spectral evidence. METEOR-BLST will collaborate with ROBIN centers to share expertise, data reporting and discovering of radiation biology. Data generated in this proposal will be shared with the scientific community subject to NIH \& institutional regulations. BLST will manage \& assist in dissemination of omics data generated. NIMS data will be deposited at MetaboLights. CODEX-based imaging data will be as supplemental files within manuscripts. Processed data will be available through CIELO. Model organisms generated will be distributed freely, or deposited into a repository/stock center.
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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.
Michael Waters, M.D., Ph.D. principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tumor collection via biopsy, Blood collection and Diffusion basis spectrum imaging (DBSI) magnetic resonance imaging (MRI) in people with Locally Advanced Cervical Carcinoma and Locally Advanced Cervical Cancer, run by Washington University School of Medicine at 1 site in United States.
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 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: looking for participants now, as of the sponsor's last update on 17 Aug 2026. 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michael Waters, M.D., Ph.D. (314-273-0275, m.r.waters@wustl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in tumor microenvironment (time frame: From start of follow-up through completion of follow-up (estimated to be 5 years)). 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 17 Aug 2026.