Hematologic NeoplasmsNCT01869218
Feasibility Study of Genomic Sequencing to Find Potential Targets for Personalized Therapy
An observational study of Hematologic Neoplasms, run by University of Colorado, Denver at 1 site in United States.
Trial summary
This study is aimed to determine the feasibility of obtaining and molecularly characterizing pre-treatment tumor biopsies, to determine the feasibility of obtaining and molecularly characterizing archival and post-treatment tumor biopsies, to assess molecular expression changes between archival and baseline tumor… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematologic Neoplasms
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Apr 2013to 15 Jan 2021
- 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 advanced solid or hematological malignancy that is resistant to standard therapy or for which no standard therapy is available. * Patients who are considered for early phase clinical trials in which an investigational agent is used either alone or in combination with chemotherapy or radiation. * Patients with a primary or metastatic tumor lesion that is amenable to biopsy or resection
Who may be able to join
- Have an advanced solid or hematological malignancy that is resistant to standard therapy or for which no standard therapy is available.
- Being considered for early phase clinical trials in which an investigational agent is used either alone or in combination with chemotherapy or radiation. Patients who decline to enroll in this companion study will not be denied participation in the primary treatment protocols. Patients who are participating in phase I-III clinical treatment trials in which a tissue biopsy is already required, or patients who have standard of care tumor biopsies or procedures planned, e.g. to confirm metastatic recurrence or palliative resection of tumor, would also be eligible for participation in this trial.
- Have a primary or metastatic tumor lesion that is amenable to biopsy or resection. Patients whose tumors cannot be safely biopsied by fine needle aspiration or core needle biopsy are still eligible to participate in the aspects of the trial involving collection of archival tumor and blood.
- Age ≥ 18 years old.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
- Life expectancy > 2 months.
Show all 11Show fewer
- Creatinine clearance ≥ 50 mL/min (applicable only if undergoing CT-guided biopsy that requires IV contrast enhancement).
- For patients with advanced solid malignancies, adequate hematologic function as defined by an absolute neutrophil count (ANC) ≥1,000/mm^3, platelet count ≥ 50,000/mm^3, white blood cell count (WBC) ≥ 3,000/ mm^3, and hemoglobin ≥ 8 g/dL.
- International normalized ratio (INR) ≤ 1.5. Patients on warfarin therapy must be able to safely withhold warfarin or be bridged with low-molecular weight therapy and demonstrate an INR ≤ 1.5 prior to the biopsy.
- Able to understand and willingness to sign a written informed consent document, agreeing to baseline and/or post-treatment tumor biopsies and/or blood collection.
- Patients who do not qualify for tumor biopsy due to laboratory abnormalities are still eligible to participate in the aspects of the trial involving collection of blood.
Who cannot join
- Have a known or suspected bleeding disorder that in the investigator's opinion would increase the risk of bleeding from a biopsy procedure. Patients who do not qualify for tumor biopsy due to a known or suspected bleeding disorder are still eligible to participate in the aspects of the trial involving collection of archival tumor and blood.
- Patients will be excluded if their participation in this study for pre-treatment biopsy, in the investigator's opinion, will significantly delay enrollment and treatment on clinical trial. Patients who are waiting for slot availability or who are undergoing a required washout from prior therapy are eligible to enroll.
- Patients with active uncontrolled bacterial, fungal or viral infection.
- Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, or in the judgment of the investigator would make the patient inappropriate for entry into the study.
- Pregnant or breast feeding.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Cancer Center
Aurora, Colorado, 80045
About this study
Official title: Feasibility Study of Genomic Sequencing to Find Potential Targets for Personalized Therapy in Patients With Advanced Malignancies
This study is aimed to determine the feasibility of obtaining and molecularly characterizing pre-treatment tumor biopsies, to determine the feasibility of obtaining and molecularly characterizing archival and post-treatment tumor biopsies, to assess molecular expression changes between archival and baseline tumor samples, and to assess molecular expression changes between tumor samples obtained at baseline and at the time of disease progression.
Read the detailed description
This study will be a companion study to existing phase I clinical trial treatment studies. It is being done to determine the feasibility of obtaining tumor tissue for genomic analysis. Patient will be offered enrollment into this trial at the time that they are being considered for participation in a phase I treatment trial. After consenting for this study, patients will undergo a fresh tumor biopsy and collection of research blood samples. Archived tumor specimens will also be obtained and analyzed. At the time of disease progression, fresh tumor biopsies and blood samples will be collected in patients who have evaluable pre-biopsy specimens and who are eligible to be screened for another study. This will be informative to evaluate the mechanisms of resistance to that agent.
- Conditions
- Hematologic Neoplasms
- Keywords
- Cancer, Advanced, Solid, Hematological, Malignancy, Tissue, Bank
- Medical subject headings
- Hematologic Neoplasms, Neoplasms
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 |
|---|---|---|
| Pre-treatment tumor biopsies | Patients who meet eligibility criteria will undergo a fresh tumor biopsy and collection of research blood samples. Archived tumor specimens will also be obtained and analyzed. At the time of disease progression, fresh tumor biopsies and blood samples will be collected in patients who have evaluable pre-biopsy specimens and who are eligible to be screened for another study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Molecularly characterizing pre-treatment tumor biopsies
As this is an exploratory, pilot feasibility study, data will be analyzed primarily with descriptive statistics. It is anticipated that this study will take up to 24-36 months to complete accrual of up to 50 patients.
Measured: Up to 24-36 months
Secondary outcomes (1)
Rate of obtaining adequate post-treatment tumor biopsies and blood samples
The rate of obtaining adequate post-treatment tumor biopsies and blood samples for molecular characterization at the time of disease progression, the rate of complications, and the rate of successful molecular characterization will be calculated and analyzed with descriptive statistics.
Measured: From date of treatment initiation until the date of first documented progression, assessed up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2013 (estimated)
- Study start2 Apr 2013
- Primary completion3 Aug 2015
- Study completion15 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematologic NeoplasmsStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- Cross-sectional
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lam Elaine, M.D, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01869218
- Sponsor's protocol ID
- 12-1025.cc
- Status last verified
- Feb 2022
- First submitted
- 28 May 2013
- Last updated
- 9 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of Genomic Sequencing to Find Potential Targets for Personalized Therapy in Patients With Advanced Malignancies
- ClinicalTrials.gov ID
- NCT01869218
- Acronym / sponsor ID
- 12-1025.cc
- Conditions
- Hematologic Neoplasms
- Keywords
- Cancer, Advanced, Solid, Hematological, Malignancy, Tissue, Bank
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 2 Apr 2013 (actual)
- Primary completion
- 3 Aug 2015 (actual)
- Study completion
- 15 Jan 2021 (actual)
- First posted
- 5 Jun 2013 (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.
This study is aimed to determine the feasibility of obtaining and molecularly characterizing pre-treatment tumor biopsies, to determine the feasibility of obtaining and molecularly characterizing archival and post-treatment tumor biopsies, to assess molecular expression changes between archival and baseline tumor samples, and to assess molecular expression changes between tumor samples obtained at baseline and at the time of disease progression.
Detailed description
This study will be a companion study to existing phase I clinical trial treatment studies. It is being done to determine the feasibility of obtaining tumor tissue for genomic analysis. Patient will be offered enrollment into this trial at the time that they are being considered for participation in a phase I treatment trial. After consenting for this study, patients will undergo a fresh tumor biopsy and collection of research blood samples. Archived tumor specimens will also be obtained and analyzed. At the time of disease progression, fresh tumor biopsies and blood samples will be collected in patients who have evaluable pre-biopsy specimens and who are eligible to be screened for another study. This will be informative to evaluate the mechanisms of resistance to that agent.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pre-treatment tumor biopsies | – | –Patients who meet eligibility criteria will undergo a fresh tumor biopsy and collection of research blood samples. Archived tumor specimens will also be obtained and analyzed. At the time of disease progression, fresh tumor biopsies and blood samples will be collected in patients who have evaluable pre-biopsy specimens and who are eligible to be screened for another study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- * Patients with advanced solid or hematological malignancy that is resistant to standard therapy or for which no standard therapy is available. * Patients who are considered for early phase clinical trials in which an investigational agent is used either alone or in combination with chemotherapy or radiation. * Patients with a primary or metastatic tumor lesion that is amenable to biopsy or resection
Key inclusion criteria (11 listed)
- Have an advanced solid or hematological malignancy that is resistant to standard therapy or for which no standard therapy is available.
- Being considered for early phase clinical trials in which an investigational agent is used either alone or in combination with chemotherapy or radiation. Patients who decline to enroll in this companion study will not be denied participation in the primary treatment protocols. Patients who are participating in phase I-III clinical treatment trials in which a tissue biopsy is already required, or patients who have standard of care tumor biopsies or procedures planned, e.g. to confirm metastatic recurrence or palliative resection of tumor, would also be eligible for participation in this trial.
- Have a primary or metastatic tumor lesion that is amenable to biopsy or resection. Patients whose tumors cannot be safely biopsied by fine needle aspiration or core needle biopsy are still eligible to participate in the aspects of the trial involving collection of archival tumor and blood.
- Age ≥ 18 years old.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
Key exclusion criteria (5 listed)
- Have a known or suspected bleeding disorder that in the investigator's opinion would increase the risk of bleeding from a biopsy procedure. Patients who do not qualify for tumor biopsy due to a known or suspected bleeding disorder are still eligible to participate in the aspects of the trial involving collection of archival tumor and blood.
- Patients will be excluded if their participation in this study for pre-treatment biopsy, in the investigator's opinion, will significantly delay enrollment and treatment on clinical trial. Patients who are waiting for slot availability or who are undergoing a required washout from prior therapy are eligible to enroll.
- Patients with active uncontrolled bacterial, fungal or viral infection.
- Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, or in the judgment of the investigator would make the patient inappropriate for entry into the study.
- Pregnant or breast feeding.
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
Molecularly characterizing pre-treatment tumor biopsies
Time frame: Up to 24-36 months
As this is an exploratory, pilot feasibility study, data will be analyzed primarily with descriptive statistics. It is anticipated that this study will take up to 24-36 months to complete accrual of up to 50 patients.
1 secondary outcome
Rate of obtaining adequate post-treatment tumor biopsies and blood samples
Time frame: From date of treatment initiation until the date of first documented progression, assessed up to 36 months
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 9 Feb 2022.
- Individual participant dataSharing planned: No
Related trials for Hematologic Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Active, not recruitingPhase 3
A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
Multiple Myeloma
Active, not recruitingPhase 1/2
A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
Multiple Myeloma
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.
Lam Elaine, M.D principal investigator
University of Colorado, Denver
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 Hematologic Neoplasms, run by University of Colorado, Denver 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 11 inclusion and 5 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 9 Feb 2022. 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?
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?
Molecularly characterizing pre-treatment tumor biopsies (time frame: Up to 24-36 months). 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 Feb 2022; AzTrials last refreshed its copy on 6 Nov 2026.