Table 1.
Information on the studies eligible for enrollment (%)
|
Ref.
|
Year
|
Country
|
Trial design
|
Disease
|
Detection method
|
Total volunteers
|
Cases (CRC)
|
Controls (non-CRC)
|
Sensitivity (95%CI)
|
Specificity (95%CI)
|
Sensitivity (95%CI)
|
Definition of a positive
|
||||||
|
Stage I
|
Stage II
|
Stage III
|
Stage IV
|
|||||||||||||||
| Symonds et al[27] | 2016 | Australia | Prospective observational study | CRC screening | Real-time PCR | 1381 | 66 | 1315 | 62 (49–74) | 92 (90–93) | 41 (18-67) | 76 (55–91) | 59 (33–82) | 71 (29–96) | At least one PCR replicate was positive | |||
| Pedersen et al[32] | 2015 | Australia | Prospective observational study | CRC screening | Real-time PCR | 218 | 74 | 144 | 77 (66-86) | 92 (86-96) | 50 (7-93) | 68 (48-84) | 87 (66-97) | 100 (63-100) | A total change in fluorescence intensity above background levels was measured within 50 PCR amplification cycles | |||
| Winter et al[30] | 2022 | Australia | Prospective observational study | CRC screening | Real-time PCR | 896 | 290 | 606 | 60 (54-66) | 92 (89-94) | 24 (14-37) | 62 (51-72) | 68 (58-77) | 91 (78-97) | Methylation levels of 10% or more | |||
| Pedersen et al[32] | 2015 | Australia | Prospective observational study | CRC screening | Real-time PCR | 967 | 129 | 838 | 66 (57-74) | 94 (92-95) | 38 (57-74) | 69 (53-82) | 73 (56-85) | 94 (70-100) | At least one PCR replicate was positive | |||
| Saluja et al[35] | 2021 | Australia | Retrospective case–control study | CRC screening | Real-time PCR | 1593 | 114 | 1479 | 61 (52-70) | 91 (90-93) | NA | NA | NA | NA | At least one PCR replicate was positive | |||
| Young et al[28] | 2016 | Australia | Prospective observational study | Recurrent CRC detection | Real-time PCR | 122 | 28 | 94 | 68 (48-84) | 87 (79-93) | 0/0 | 75 (35-97) | 71 (44-90) | 33 (1-91) | At least one PCR replicate was positive | |||
| Symonds et al[29] | 2020 | Australia | Prospective observational study | Recurrent CRC detection | Real-time PCR | 144 | 50 | 94 | 66 (57-69) | 98; (93 -100) | 0/0 | 69 (39-91) | 70 (51-85) | 43 (10-82) | COLVERA (Clinical Genomics Pty, Ltd, North Ryde, New South Wales Australia) detectability of ctDNA | |||
| Pedersen et al[26] | 2023 | Australia | Prospective observational study | Recurrent CRC detection | Real-time PCR | 142 | 33 | 109 | 27 (13-46) | 91 (84-96) | NA | NA | NA | NA | 0.07% | |||
| Pedersen et al[31] | 2022 | Australia | Prospective observational study | Recurrent CRC detection | Real-time PCR | 549 | 77 | 472 | 64 (52-74) | 98 (96-99) | NA | NA | NA | NA | 0.07% | |||
| Musher et al[33] | 2020 | United States | Prospective observational study | Recurrent CRC detection | Real-time PCR | 322 | 27 | 295 | 63 (42-81) | 92 (88-94) | NA | NA | NA | NA | COLVERA (clinical Genomics Pathology Inc., NJ, United States) detectability of ctDNA | |||
| Symonds et al[34] | 2022 | Australia | Prospective observational study | Recurrent CRC detection | Real-time PCR | 55 | 10 | 45 | 70 (35-93) | 87 (73-95) | NA | NA | NA | NA | At least one PCR replicate was positive | |||
| Murray et al[36] | 2018 | Australia | Prospective observational study | recurrent CRC detection | real-time PCR | 172 | 23 | 149 | 30 (13-53) | 86 (79-91) | NA | NA | NA | NA | At least one PCR replicate | |||
CRC: Colorectal cancer; CI: Confidence interval; PCR: Polymerase chain reaction; ctDNA: Circulating tumor DNA; NA: Not available.