Hematopoietic and Lymphoid System NeoplasmNCT05530759
Examining Blood and Tissue Samples to Identify Diagnostic Markers in Patients With Metastatic Cancer Undergoing Tumor Removal
An observational study of Hematopoietic and Lymphoid System Neoplasm and Metastatic Malignant Solid Neoplasm, run by Mayo Clinic at 1 site in United States.
Trial summary
This study characterizes deoxyribonucleic acid (DNA) and proteomic (protein) changes in both biopsies and tumors removed during surgery of patients who have been diagnosed with aggressive/metastatic (that has spread to other places in the body) cancer in order to identify possible diagnostic markers and potential… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematopoietic and Lymphoid System Neoplasm, Metastatic Malignant Solid Neoplasm
- What is being tested?
- Biopsy Specimen, Biospecimen Collection and Archived Biospecimen Collection
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jun 2022to 30 Apr 2031
- Phase
- Observational
- 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
Study population: Participants will be identified internally through provider referrals most commonly from providers in Medical Oncology.
Who may be able to join
- Patients (or the legally authorized representative/guardian signing on behalf of the participant) must understand and provide written informed consent prior to initiation of any study-specific procedures
- >= 18 years of age
- Patients must have a diagnosis of confirmed malignancy
- Patient is a good medical candidate for a standard of care biopsy or surgical procedure to obtain tissue or has archival tissue available for analysis
Who cannot join
- Uncontrolled concurrent illness including psychiatric illness, or situations that would limit compliance with the study requirements or the ability to willingly give written informed consent
- Inaccessible tumor for biopsy or patient does not have tumor tissue available for research use
- Biopsy must not be considered to be more than minimal risk to the patient. Contraindications to percutaneous biopsy:
- Significant coagulopathy that cannot be adequately corrected
- Severely compromised cardiopulmonary function or hemodynamic instability
- Lack of a safe pathway to the lesion
- Inability of the patient to cooperate with, or to be positioned for, the procedure
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
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Clinical Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu
Aaron S. Mansfield, M.D.
About this study
Official title: Integrated Genomics and Patient-Derived Cancer Models
This study characterizes deoxyribonucleic acid (DNA) and proteomic (protein) changes in both biopsies and tumors removed during surgery of patients who have been diagnosed with aggressive/metastatic (that has spread to other places in the body) cancer in order to identify possible diagnostic markers and potential drugs for treating aggressive tumor types. Proteomic analyses include looking at the proteome, or all the proteins expressed, or made by DNA at a specific moment in time. Studying samples of blood, buccal (cheek), and tissue in the laboratory from patients undergoing surgical resection or biopsy may help doctors learn more about the changes that occur in the proteome, DNA alterations, and identify molecular biomarkers for which therapeutic drugs may exist. Studying the DNA in tumor tissue and in blood may also help researchers see if the tumor has important differences.
Read the detailed description
PRIMARY OBJECTIVES:
- To understand the pathogenesis, molecular mechanisms, and disease processes of malignancies.
II. To examine the utility of integrated genomics for discovery of targets or pathways involved in tumor/malignancy progression of patients with malignancies.
III. To observe for any evidence of anti-tumor activity from treatment if selected based on integrated genomics.
IV. To create and offer opportunities for targeted individualized therapy based on the outcome of integrated genomics and micro-cancer modeling.
- To determine the outcome of patients with malignancies who received targeted individualized therapy.
OUTLINE: This is an ancillary-correlative study.
Patients undergo collection of blood and buccal samples before or after standard of care (SOC) biopsy or tumor resection. Patients undergo collection of tumor tissue at time of SOC biopsy or tumor resection. Patients' medical records are also reviewed. Patients' archived tissue or blood samples may also be collected.
- Being tested
- Biopsy Specimen, Biospecimen Collection, Archived Biospecimen Collection, Medical Chart Review
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biopsy SpecimenProcedure or surgery
Also called Biopsy Sample
Undergo collection of tissue samples
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection
Undergo collection of blood and buccal swab samples
Archived Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Biospecimen Collection, Specimen Collection
Undergo collection of archived tissue and blood samples
Medical Chart ReviewOther
Also called Chart Review
Review of medical record
| Study group | Role | What they receive |
|---|---|---|
| Ancillary-Correlative (biospecimen collection) | Patients undergo collection of blood and buccal samples before or after SOC biopsy or tumor resection. Patients undergo collection of tumor tissue at time of SOC biopsy or tumor resection. Patients' medical records are also reviewed. Patients' archived tissue or blood samples may also be collected. Receives: Procedure: Biopsy Specimen; Procedure: Biospecimen Collection; Procedure: Archived Biospecimen Collection; Other: Medical Chart Review |
What is being measured
The primary outcome is the main question the study is designed to answer.
Deoxyribonucleic acid (DNA) alterations
identify molecular targets for which therapeutic drugs may exist
Measured: Through study completion; up to five years
Proteomic changes in both biopsies and resected tumors
identify molecular targets for which therapeutic drugs may exist
Measured: Through study completion; up to five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2022
- Study start29 Jun 2022
- Primary completion30 Apr 2031 (estimated)
- Study completion30 Apr 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematopoietic and Lymphoid System NeoplasmStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Other
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aaron S. Mansfield, M.D., Principal investigator, Mayo Clinic in Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05530759
- Sponsor's protocol ID
- 21-008623
- Status last verified
- Jun 2026
- First submitted
- 31 Aug 2022
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrated Genomics and Patient-Derived Cancer Models
- ClinicalTrials.gov ID
- NCT05530759
- Acronym / sponsor ID
- 21-008623
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 29 Jun 2022 (actual)
- Primary completion
- 30 Apr 2031 (estimated)
- Study completion
- 30 Apr 2031 (estimated)
- First posted
- 7 Sep 2022 (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 characterizes deoxyribonucleic acid (DNA) and proteomic (protein) changes in both biopsies and tumors removed during surgery of patients who have been diagnosed with aggressive/metastatic (that has spread to other places in the body) cancer in order to identify possible diagnostic markers and potential drugs for treating aggressive tumor types. Proteomic analyses include looking at the proteome, or all the proteins expressed, or made by DNA at a specific moment in time. Studying samples of blood, buccal (cheek), and tissue in the laboratory from patients undergoing surgical resection or biopsy may help doctors learn more about the changes that occur in the proteome, DNA alterations, and identify molecular biomarkers for which therapeutic drugs may exist. Studying the DNA in tumor tissue and in blood may also help researchers see if the tumor has important differences.
Detailed description
PRIMARY OBJECTIVES:
- To understand the pathogenesis, molecular mechanisms, and disease processes of malignancies.
II. To examine the utility of integrated genomics for discovery of targets or pathways involved in tumor/malignancy progression of patients with malignancies.
III. To observe for any evidence of anti-tumor activity from treatment if selected based on integrated genomics.
IV. To create and offer opportunities for targeted individualized therapy based on the outcome of integrated genomics and micro-cancer modeling.
- To determine the outcome of patients with malignancies who received targeted individualized therapy.
OUTLINE: This is an ancillary-correlative study.
Patients undergo collection of blood and buccal samples before or after standard of care (SOC) biopsy or tumor resection. Patients undergo collection of tumor tissue at time of SOC biopsy or tumor resection. Patients' medical records are also reviewed. Patients' archived tissue or blood samples may also be collected.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ancillary-Correlative (biospecimen collection) | – | Procedure: Biopsy Specimen, Procedure: Biospecimen Collection, Procedure: Archived Biospecimen Collection, Other: Medical Chart ReviewPatients undergo collection of blood and buccal samples before or after SOC biopsy or tumor resection. Patients undergo collection of tumor tissue at time of SOC biopsy or tumor resection. Patients' medical records are also reviewed. Patients' archived tissue or blood samples may also be collected. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be identified internally through provider referrals most commonly from providers in Medical Oncology.
Key inclusion criteria (4 listed)
- Patients (or the legally authorized representative/guardian signing on behalf of the participant) must understand and provide written informed consent prior to initiation of any study-specific procedures
- >= 18 years of age
- Patients must have a diagnosis of confirmed malignancy
- Patient is a good medical candidate for a standard of care biopsy or surgical procedure to obtain tissue or has archival tissue available for analysis
Key exclusion criteria (7 listed)
- Uncontrolled concurrent illness including psychiatric illness, or situations that would limit compliance with the study requirements or the ability to willingly give written informed consent
- Inaccessible tumor for biopsy or patient does not have tumor tissue available for research use
- Biopsy must not be considered to be more than minimal risk to the patient. Contraindications to percutaneous biopsy:
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 |
|---|---|---|
| Biopsy SpecimenAlso: Biopsy SampleUndergo collection of tissue samples | Procedure or surgery | Ancillary-Correlative (biospecimen collection) |
| Biospecimen CollectionAlso: Biological Sample Collection, Biospecimen Collected, Specimen CollectionUndergo collection of blood and buccal swab samples | Procedure or surgery | Ancillary-Correlative (biospecimen collection) |
| Archived Biospecimen CollectionAlso: Biological Sample Collection, Biospecimen Collected, Biospecimen Collection, Specimen CollectionUndergo collection of archived tissue and blood samples | Procedure or surgery | Ancillary-Correlative (biospecimen collection) |
| Medical Chart ReviewAlso: Chart ReviewReview of medical record | Other | Ancillary-Correlative (biospecimen collection) |
Primary outcome
Deoxyribonucleic acid (DNA) alterations
Time frame: Through study completion; up to five years
identify molecular targets for which therapeutic drugs may exist
Proteomic changes in both biopsies and resected tumors
Time frame: Through study completion; up to five years
identify molecular targets for which therapeutic drugs may exist
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 9 Jun 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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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.
Aaron S. Mansfield, M.D. principal investigator
Mayo Clinic in Rochester
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 Hematopoietic and Lymphoid System Neoplasm and Metastatic Malignant Solid Neoplasm, run by Mayo Clinic 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 4 inclusion and 7 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 9 Jun 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Deoxyribonucleic acid (DNA) alterations (time frame: Through study completion; up to five years). 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?
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 9 Jun 2026.