The primary objective of this study is to obtain clinically characterized, whole blood specimens from subjects with a new or suspected diagnosis of cancer (cancer subjects) and from subjects who do not have a diagnosis of cancer (healthy) to develop…
ID
Source
Brief title
Condition
- Other condition
- Miscellaneous and site unspecified neoplasms benign
Synonym
Health condition
single blood draw for early detect of cancer
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The purpose of this study is to obtain clinically characterized, whole blood
specimens from cancer subjects and healthy subjects to develop and refine
assays for cancer in the blood.
Secondary outcome
N/A
Background summary
Cancer is the second leading cause of death in the United States, with an
estimated 600,000 people expected to die from the disease this year. Most of
these cancers are often detected too late, and only after people start to
experience symptoms. These *symptom-detected* cancers too
frequently coincide with late stage, metastatic disease, and result in poor
outcomes. However, when cancer is detected through screening, or are *screen-
detected,* the disease is often identified earlier when it can be more
effectively treated, and in many cases even cured.
CancerSEEK is a blood test designed to detect multiple types of cancer at the
earliest stages possible. The CancerSEEK test has been shown in both
retrospective and prospective settings to be able to detect many different
types of cancer for which routine,
SOC screening modalities are not presently available.
CancerSEEK as a minimally invasive multi cancer screening test, employed in a
complementary fashion with currently approved SOC cancer screening approaches
may be able to increase cancer detection rates.
Study objective
The primary objective of this study is to obtain clinically characterized,
whole blood specimens from subjects with a new or suspected diagnosis of cancer
(cancer subjects) and from subjects who do not have a diagnosis of cancer
(healthy) to develop and refine assays for cancer in the
blood.
Study design
This is a prospective study of cancer and healthy subjects that will be
conducted in the United States and parts of Europe (Germany,
Hungary, France, United Kingdom, and the Netherlands). Enrollment of
approximately 32,000 subjects overall is anticipated with approximately
8,000 stage I-IV cancer subjects and approximately 24,000 healthy subjects.
Enrollment into the study will occur after eligibility is confirmed and
informed consent obtained. Once informed consent is obtained, subject
data will be collected and subjects will undergo an approximate 51mL blood
draw, at which time their participation in the study will be
considered complete. Blood will be packaged and sent to a central laboratory
for processing and analyses per sample collection and shipping
instructions provided by the Sponsor.
Study burden and risks
Subjects will undergo 1 blood draw.
Risk from blood draw is minimal. During or after bloods draws, subject may have
pain, swelling, or bruising where the needle enters the vein. There may be risk
of infection. Subject may feel dizzy or faint.
As there are no benefits to subjects enrolled in this study. Participation will
help in the search for improved cancer diagnosis which may benefit future
cancer patients.
Jacobs Street, 9th Floor 222
Cambridge MA 02141
US
Jacobs Street, 9th Floor 222
Cambridge MA 02141
US
Listed location countries
Age
Inclusion criteria
All subjects
1. >=50 years of age
2. Subject understands the study procedures and is able to provide informed
consent to participate in the study and authorization for release of relevant
protected health information to the study investigator.
Cancer Subjects Only
3. Subject has an untreated primary malignancy of breast, lung, colorectal,
prostate, bladder, uterine, kidney/renal pelvis, pancreatic, liver, stomach,
ovarian, esophageal cancer, head and neck squamous cell, thyroid, small
intestine, cervical, anal, vulva, or testis confirmed through pathology reports
and/or clinical/radiographic data.
Or
4. Subject has suspicion of a primary malignancy of pancreatic, bladder,
kidney/renal pelvis, testis or ovarian cancer based on imaging.
Exclusion criteria
1. Prior or concurrent cancer diagnosis defined as:
a. Any previous cancer diagnosis within the past 5 years (with the exceptions
of basal cell or squamous cell skin cancers); OR
b. Recurrence of the same primary cancer within any timeframe; OR
c. Concurrent diagnosis of multiple primary cancers
2. Chemotherapy and/or radiation therapy within 5 years prior to
enrollment/sample collection.
3. Any treatment for the primary malignancy or sites of metastases. Subject may
not have started neo-adjuvant chemotherapy, neo-adjuvant radiation therapy,
immunotherapy or other treatment and/or surgery prior to blood sample
collection.
4. Less than 3 days between fine needle aspiration (FNA) of target pathology
and blood collection.
5. Less than 7 days between biopsy (other than FNA) of target pathology and
blood collection.
6. IV contrast (e.g., CT and MRI) within 1 day [or 24 hours] prior to blood
collection.
7. Individual has a condition the Investigator believes would interfere with
the subject*s ability to provide informed consent, comply with the study
protocol, which might confound the interpretation of the study results or put
the person at undue risk.
8. Participant has an active febrile infection prior to blood draw
9. History of an allogeneic bone marrow, stem cell transplant, or solid organ
transplant
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL80557.091.22 |