Cervix

RISK FACTORS

ASSOCIATED WITH CONVENTIONAL INVASIVE CERVICAL BIOPSIES

  • Hemorrhage
  • Pelvic infection
  • Problems with sedation or anesthesia
  • Morbidity

RISK FACTORS

ASSOCIATED WITH CONVENTIONAL INVASIVE CERVICAL BIOPSIES

  • Hemorrhage
  • Pelvic infection
  • Problems with sedation or anesthesia
  • Morbidity

Cervix

ADVANTAGES OF TRUBLOOD

  • Blood based, Non-invasive
  • Safe
  • Accurate
  • Easy on the Patient
  • Reasonable Charges
  • Available for all solid organs

WHO WILL BENEFIT

Symptomatic individuals who have been advised a biopsy to check for malignancy.
Patients where an invasive biopsy has been inconclusive or inconsistent with clinical observations.
Suspected metastatic relapse to rule out new primary.

RADIOLOGICAL SIGNS OF CERVICAL MALIGNANCIES

  • Hypoechoic, heterogeneous mass involving the cervix.
  • An enlarged cervix with normal contrast enhancement.
  • An enlarged cervix with inhomogeneous areas of hypoattenuation but without a discrete mass.
  • An enlarged cervix with a circumscribed solid mass with homogeneous or heterogeneous hypoattenuation.
  • Increased vascularity on color Doppler.

IMMUNOCYTOCHEMISTRY

DIAGNOSTIC

EpCAM
PanCK
CK7
CD45
Chromogranin A
Synaptophysin
P63
CEA
P16
ER

EMT

Vimentin
N-CAD
CD44

cfDNA+RNA

HOTSPOT GENES

AKT1
ALK
APC
AR
ARAF
BRAF
CHEK2
CTNNB1
DDR2
EGFR
ERBB2
ERBB3
ESR1
FBXW7
FGFR1
FGFR2
FGFR3
FGFR4
FLT3
GNA11
GNAQ
GNAS
HRAS
IDH1
IDH2
KIT
KRAS
MAP2K1
MAP2K2
MET
MTOR
NRAS
NTRK1
NTRK3
PDGFRA
PIK3CA
PTEN
RAF1
RET
ROS1
SF3B1
SMAD4
SMO
TP53

COPY NUMBER GENES (CNVs)

CCND1
CCND2
CCND3
CDK4
CDK6
EGFR
ERBB2
FGFR1
FGFR2
FGFR3
MET
MYC

GENE FUSIONS

ALK
BRAF
ERG
ETV1
FGFR1
FGFR2
FGFR3
MET
NTRK1
NTRK3
RET
ROS1

MET exon 14 skipping

PD-L1, cfDNA, FISH and Pharmacogenetics are optional and at extra cost

SPECIMEN REQUIREMENTS

BASIC DIAGNOSTICS

1st Draw
2ml SST Tube
(Yellow colour cap).

2nd Draw
3 x EDTA Tubes (Purple Colour Cap)
of 5 ml each – total 15 ml.

Thus, total 4 tubes containing 17 ml whole blood.

BASIC DIAGNOSTICS + cfDNA + RNA + FISH + PHARMACOGENETICS

1st Draw
2ml SST Tube
(Yellow colour cap).

2nd Draw
8ml DCG Tube
(Brown Colour Cap).

3rd Draw
3 x EDTA Tubes (Purple Colour Cap)
of 5 ml each – total 15 ml.

Thus, total 5 tubes containing 25 ml whole blood.

Note :

    • Sequence of draw should not be altered.
    • Blood should be drawn only and only as per above method.
    • Blood drawn should be performed only by qualified phlebotomist under medical supervision.
    • Ship 4 °C in the container provided by DCG.

OTHER PRECAUTIONS PRIOR TO COLLECTION OF BLOOD SAMPLE

  • The patient must not have received any form of cancer therapy (radiation / chemotherapy / surgery / endocrine etc.) at least 30 days prior to collection of sample.
  • The patient must not have received oral or IV corticosteroids at least 14 days prior to collection of sample.
  • Patient has no current febrile or any other acute inflammatory illness.
  • Patient does not have acute exacerbation or flareup of an inflammatory condition requiring escalation in medical therapy at least 5 days prior to collection of sample.
  • Patient has not received blood transfusion / PET-CT / CTscan at least 5 days prior to collection of sample.
  • Patient is not positive for HIV / HBV / HCV.

VALIDATION

Trublood® non-invasive diagnostic biopsy for solid organ cancers has been developed by Datar Cancer Genetics based on the findings of two clinical trials registered with the CTRI (Registration No. CTRI/2019/01/017219 and CTRI/2019/03/ 017918).

Trublood has been extensively validated with data from more than 22,000 samples from asymptomatic individual donors who underwent currently used screening tests such as LDCT, Mammography, PAP Smear, Serum CA Markers and clinical examinations, as well as more than 18,000 samples from cancer patients / patients with benign conditions totalling more than 40,000 evaluable samples till December, 2019.

EVALUTED SAMPLES (PATIENTS)

Cancer Type Patients
Breast 3967
Head and Neck 3552
Lung 1378
Colorectal 1341
Prostate 1196
Cervix 930
Ovary 855
Esophagus 507
Sarcoma 440
Stomach 392
Uterus + Endometrium 365
Pancreas 385
Liver 381
CNS 349
Kidney 342
Bladder 249
Bone 220
Gallbladder 196
Thyroid 175
Testes 135
Skin 115
Melanoma 86
Penis 72
Neuroendocrine 51
Others 154
Total 17,833

SUMMARY

Particulars Samples
All Cancers 17,833
Benign Conditions 488
Asymptomatic Individuals 22,030
Total 40,351

BASIS

  • Tumors release thousands of cells into the circulation, where circulating tumor cells (CTCs) survive for about 1–2.5 hours.
  • In order to detach from the primary tumor and disseminate into the blood, cells must undergo a cellular process known as Epithelial-Mesenchymal Transition (EMT).
  • EMT enhances migratory capabilities of tumor cells, which allows cells to penetrate into the vasculature and circulate as single or clusters of circulating tumor cells (CTCs).
  • CTCs extravasate having undergone the reverse process known as Mesenchymal to Epithelial Transition (MET) and colonize at distant organs.
  • Circulating Tumor Cells (CTCs) are defined as EpCAM (+), PanCK (+), CD45 (-) cells. Circulating Tumor Associated Cells (C-TACs) are EpCAM(+), PanCK(+), CD45(+/-) cells of tumorigenic origin, in peripheral blood.
  • Non-tumorigenic cells in peripheral blood have functional apoptotic mechanism, but CTC and C-TACs are resistant to apoptosis.
  • An epigenetically active stabilizing process can eliminate normal cells and confer survival privilege on apoptosis – resistant C-TACs, CTC and C-TACs.
  • Sufficient C-TACs can be enriched and harvested for Immunocytochemistry (ICC) profiling with markers used in immunohistochemistry (IHC) which aid in determination of histopathological subtypes of tumor tissue.
  • Antibody clones used in the trublood® assay for analysis of tumor antigens/markers are internationally approved for IVD use.

DOWNLOAD BROCHURE + SAMPLE REPORT

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On my request, Datar Cancer Genetics (DCG) has agreed to permit me to access and download a copy of the specimen Test Report for 'Trublood' on the following express conditions which I hereby declare are binding on me and also declare that but for such acceptance by me, DCG would not have permitted me to download and obtain printout of the said specimen report. I have read the Terms and Conditions set out below carefully and after full consideration and understanding my responsibility, and the fact that the information is provided to me for my bona fide personal use and made available in 'trust', I subscribe to the same as under:



Terms and Conditions:

  • I have correctly declared my true legal name in the information submitted at the time of my request.
  • That I am a person above the age of 18 years and legally competent to enter into a lawful and binding contract.
  • That I expressly recognize and do not dispute that DCG is the sole Copyright holder and Intellectual Property holder in respect of all contents in regard to the test procedure, the process of analysis, layout and contents of the Report, the design and artwork and all such other intangible and intellectual property of DCG which is materially related to the said Report and I undertake not to infringe and/or prejudicially use and/or disclose to any third person the said information / report / material particulars to the prejudice of DCG.
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  • I solemnly declare as above.

FREQUENTLY ASKED QUESTIONS

Can Trublood® detect all cancers?

Trublood® detects presence of carcinoma i.e. epithelial malignancies, melanoma as well as certain subtypes of sarcoma. It does not detect haematolymphoid malignancies. Carcinomas are the most common malignancy in adults.

Can Trublood® differentiate between squamous cell carcinoma and adenocarcinoma?

Can Trublood® always provide specific histopathological subtype? Can it identify rare HPE subtype?

Can Trublood® give us the histological grade of the tumor?

What is the principle used in Trublood®?

How is Trublood® different from a Circulating Tumor Cell (CTC) test?

Can I use Trublood® for longitudinal CTC enumeration?

Can you find CTCs in blood when there is Carcinoma in situ? / Can Trublood® identify carcinoma in situ?

Can you find CTCs in early stage cancer?

How does it give guidance for therapy?

How does it differ from other cancer screening methods e.g. CA125, CA19-9, etc.?

Can Trublood® be offered to a person with non-specific cancer symptoms such as cachexia without clinical suspicion of a particular organ involvement?

How is the sample collected? Is there any special procedure for collection?

How is the sample transported?

What is the next step if Trublood® gives positive result?

Do I need to confirm the presence of malignancy with an invasive biopsy when Trublood® results are positive?

Do you have any comparative data?

How is the performance of Trublood®? What is the validation you have for this test?

Is it being used by clinicians anywhere?

What if the test is inconclusive?

Can Trublood® be availed for childhood malignancies?

What advantage does Trublood® offer over tissue biopsy?

What are the limitations of Trublood®?

Can Trublood® give theragnostic information similar to that obtained by tissue biopsy?

Will doctor treat me based on Trublood® result?

Can Trublood® be used in haematological malignancies?

CONTACT US

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