Genetic Exploration of the Molecular Basis of Malignancy in Adults

NCT02416518 | Completed DMC

• 1 other identifier: SH GEMMA
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 4

Brief Summary

Genetic Exploration of the Molecular Basis of Malignancy in Adults.

Conditions

Neoplasms

Keywords

Cancer; Malignancy; Genomic; Molecular

Outcome Measures

Primary Outcomes (1)

• Feasibility (proportion of patients with successful molecular profiling compared to the number of patients enrolled)

  Assess the feasibility of integrating genomic profiling in the adult oncology clinic within a community-based, multi-facility, health system. Feasibility is defined as the proportion of patients with successful molecular profiling compared to the number of patients enrolled.

  12 months

Secondary Outcomes (4)

• Patient and biopsy characteristics (including cancer type, biopsy type, and number of prior treatments)

  12 months

• Molecular testing characteristics (include: the frequency at which molecular analysis yields a genetic alteration, frequency of actionable alterations, and time from biopsy to final report)

  12 months

• Molecular profiling influence

  12 months

• Clinical outcome of genomic based therapy (response according to RECIST 1.1 response criteria)

  At 16wks following initiation of treatment impacted by molecular profiling. After 16wks tumor assessments per routine practice/clinical trial protocol requirements, continued until progression/time of treatment discontinuation, whichever is later.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with metastatic, incurable cancer or cancer with no standard 1st-line systemic therapy that has shown prolonged survival

You may qualify if:

• Understand and provide written informed consent and HIPAA Authorization prior to initiation of any study-specific procedures.
• Have a life expectancy of \>3 months.
• Have a diagnosis of metastatic, incurable cancer and have progressed on at least one line of systemic therapy OR a cancer with no standard 1st-line systemic therapy shown to prolong survival (or where a clinical trial recommended as the 1st-line option). Patients do not have to be off-treatment when enrolled on this trial. However, please see section 6.4.8 regarding the required wash-out period before starting any FDA approved on-label or off-label treatment.
• Measurable disease (RECIST 1.1).
• Be ≥18 years of age.
• ECOG Performance status 0 or 1.
• In the opinion of the investigator, be medically suitable for and willing to undergo a biopsy or surgical procedure to obtain tissue as a part of routine care for their malignancy OR have adequate archival tissue from a previous biopsy, performed no more than 14 weeks prior to enrollment, available for profiling.
• Have adequate organ and bone marrow function as defined below: Bone marrow: absolute neutrophil count (ANC) ≥ 1.5 x 109/L; hemoglobin ≥ 9 g/dL; platelets \>100 x 109/L Renal: creatinine clearance ≥ 60 mL/min (calculated according to Cockcroft and Gault formula) or creatinine ≤ 1.5 mg/dL Hepatic: bilirubin ≤ 2.5 x the upper limit of normal (ULN); aspartate transaminases (AST/SGOT); alanine transaminases (ALT/SGPT) ≤ 2.5 x ULN (or ≤ 5 x ULN if due to underlying liver metastases)
• Female patients of childbearing potential must have a negative pregnancy test and agree to use at least two forms of contraception during the study and for at least one month after treatment discontinuation. For the purposes of this study, a female with child- bearing potential is defined as: any woman who meets the following criteria.
• Has not undergone a hysterectomy or bilateral oophorectomy. Has not been naturally postmenopausal for at least 24 months (i.e. has had a menses at any time in the preceding 24 consecutive months).
• Male patients must use a form of barrier contraception that contains spermicide and is approved by the investigator / treating physician during the study and for at least one month after treatment discontinuation.
• No more than one prior screening attempt for SH GEMMA.

You may not qualify if:

• Have lesions that are not accessible to biopsy or not planned for biopsy as part of routine care OR if archival tissue will be used for profiling, an insufficient amount is available OR archival tissue was obtained ≥ 14 weeks prior to enrollment.
• Have diagnosis of a hematologic malignancy.
• Diagnosis of astrocytoma, glioblastoma multiforme, or any other primary brain cancer.
• Have concurrent uncontrolled malignancy.
• Have symptomatic CNS metastasis. Patients with a history of CNS metastases who have been treated with whole brain irradiation must be stable without symptoms for 4 weeks after completion of treatment, with image documentation required, and must be either off steroids or on a stable dose of steroids for ≥ 2 weeks prior to enrollment.
• Have uncontrolled concurrent illness including, but not limited to, ongoing or active serious infection, symptomatic congestive heart failure, unstable angina pectoris, unstable cardiac arrhythmias, psychiatric illness, or situations that would limit compliance with the study requirements or the ability to willingly give written informed consent.
• Have known HIV, HBV, HCV infection.
• Previous enrollment in the SH GEMMA study. Patients are allowed one prior screening attempt.
• Are pregnant or breast-feeding patients or any patient with childbearing potential not using adequate contraception.

Sponsors & Collaborators

• Sanford Health: lead

Study Sites (4)

Sanford Health

Bemidji, Minnesota, 56601, United States

Location

Sanford Health

Bismarck, North Dakota, 58501, United States

Location

Sanford Health

Fargo, North Dakota, 57102, United States

Location

Sanford Health

Sioux Falls, South Dakota, 57104, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Tissue and blood samples

MeSH Terms

Conditions

Neoplasms

Study Officials

• Steven Powell, MD

  Sanford Health

  PRINCIPAL INVESTIGATOR

• Anu Gaba, MD

  Sanford Health

  PRINCIPAL INVESTIGATOR

• John Reynolds, MD

  Sanford Health

  PRINCIPAL INVESTIGATOR

• Jayan Nair, MD

  Sanford Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2014
• First Posted: April 15, 2015
• Study Start: May 1, 2014
• Primary Completion: March 1, 2018
• Study Completion: December 1, 2018
• Last Updated: April 2, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)