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CompletedNCT01869218Updated Feb 9, 2022

Feasibility Study of Genomic Sequencing to Find Potential Targets for Personalized Therapy

An observational study in Hematologic Neoplasms, sponsored by University of Colorado, Denver. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-02-09.

Sponsored by University of Colorado, Denver · Observational

Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
40
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Hematologic Neoplasms

Keywords

  • Cancer
  • Advanced
  • Solid
  • Hematological
  • Malignancy
  • Tissue
  • Bank
03

In context

Hematologic Neoplasms

1,464 studies on the registry are indexed under Hematologic Neoplasms; 433 are open to participants now.

This study's enrollment of 40 is below the median of 186 across 326 observational studies indexed under Hematologic Neoplasms.

Browse Hematologic Neoplasms studies →

Lead sponsor

University of Colorado, Denver is the lead sponsor of 1,499 studies on the registry; 315 are open to participants now.

Of its 139 completed or terminated interventional studies of FDA-regulated products, 89 (64%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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

Inclusion criteria

  • 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.
  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
40 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 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.

    Time frame: From date of treatment initiation until the date of first documented progression, assessed up to 36 months

07

Study locations

1 site
  • University of Colorado Cancer Center
    Aurora, Colorado 80045, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 9, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01869218
Lead sponsor
University of Colorado, Denver
Responsible party
Sponsor
First posted
Jun 5, 2013
Start date
Apr 2, 2013
Primary completion
Aug 3, 2015
Completion
Jan 15, 2021
Last update
Feb 9, 2022

Study contacts

Lam Elaine, M.D
principal investigator · University of Colorado, Denver

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.

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